Semaglutide for weight loss

In the 68-week STEP 1 trial, adults with obesity, or overweight plus a weight-related condition, and without diabetes lost about 15% of body weight on average on semaglutide 2.4 mg, versus about 2% on placebo, and results varied. Wegovy injection carries a boxed warning about thyroid C-cell tumors seen in rodents. Wegovy injection (under the skin) and Wegovy tablets (by mouth) are FDA-approved for weight management in certain people; Ozempic injection, Ozempic tablets and Rybelsus tablets are approved only for adults with type 2 diabetes (checked September 27, 2026).
Overview: What is semaglutide, and what is it used for?
Semaglutide is a GLP-1 receptor agonist: according to the Wegovy prescribing information, it selectively binds to and activates the GLP-1 receptor, the target for the natural hormone GLP-1 [1]. Semaglutide products are sold under three brand names: Ozempic, Wegovy and Rybelsus. One brand name can cover more than one semaglutide product, such as an injection and a tablet, and approved uses differ by product.
Ozempic and Wegovy are different brands of semaglutide, and each of the two brands includes both an injection and a tablet. Wegovy and Ozempic both contain the same medicine, semaglutide, but the two brands come in different doses and have separate FDA prescribing information [1][2]. Semaglutide is the active ingredient in Wegovy, Ozempic and Rybelsus, which are covered by three FDA prescribing information documents: one for Wegovy injection and Wegovy tablets, one for Ozempic injection, and one for Rybelsus tablets and Ozempic tablets [1][2][3].
Tirzepatide is a separate medicine, and the head-to-head figures in this page's two tables come from one trial, SURMOUNT-5. The STEP 1 and SELECT trials enrolled adults without diabetes.
Mechanism: How does semaglutide (a GLP-1 medicine) work for weight loss?
The Wegovy label says GLP-1 is a natural regulator of appetite and calorie intake, and that semaglutide decreases calorie intake, likely by affecting appetite [1]. The Wegovy label says semaglutide delays gastric emptying, which means it slows stomach emptying [1].
Knowing how a medicine acts is not evidence that it helps; the weight-loss results on this page come from clinical trials. The STEP 1 results are trial averages, not a promise of the result for any one person.
Why people use it
A 2026 American College of Physicians guideline suggests semaglutide or tirzepatide, with lifestyle changes, as first-line medicines in outpatient settings for nonpregnant adults with obesity (BMI 30 or higher) and for adults with overweight (BMI 27 to 30) who also have type 2 diabetes, dyslipidemia, high blood pressure, obstructive sleep apnea or cardiovascular disease; this is a conditional recommendation based on moderate-certainty evidence [4]. Approved uses differ by semaglutide product.
Evidence: Does semaglutide work for weight loss? What does the research show?
In the 68-week STEP 1 trial, which was funded by semaglutide's manufacturer, 1,961 adults with obesity, or overweight plus a weight-related condition, and without diabetes took semaglutide 2.4 mg or placebo once weekly, each with a lifestyle intervention. On average, participants lost about 15% of body weight with semaglutide, compared with about 2% with placebo [5]. Results varied from person to person: in the Wegovy prescribing information's 68-week injection trial in 1,961 adults without diabetes, about 1 in 6 people taking Wegovy 2.4 mg (16.5%) did not lose at least 5% of their body weight [1].
SELECT was a larger trial, designed to count cardiovascular events, in a different group of people from STEP 1: adults aged 45 or older with established cardiovascular disease.
| Trial | Design | n | Population | Duration | Finding | Evidence level | Year | Source |
|---|---|---|---|---|---|---|---|---|
| STEP 1 [5] | Double-blind RCT, phase 3, funded by semaglutide's manufacturer | 1,961 | Adults with obesity, or overweight plus a weight-related condition, without diabetes | 68 weeks | Mean weight change −14.9% (semaglutide 2.4 mg) vs −2.4% (placebo); treatment difference −12.4 percentage points | Established | 2021 | doi.org/10.1056/NEJMoa2032183 |
| STEP 1 extension [6] | Off-treatment follow-up of an RCT subset, funded by semaglutide's manufacturer | 327 | STEP 1 participants followed after stopping semaglutide at week 68 | To week 120 | Regained 11.6 of the 17.3 percentage points lost (about two-thirds); net loss at week 120: 5.6% vs 0.1% (placebo) | Emerging (follow-up of one trial funded by semaglutide's manufacturer) | 2022 | doi.org/10.1111/dom.14725 |
| STEP 4 [7] | Randomized withdrawal RCT, double-blind, funded by semaglutide's manufacturer | 803 | Adults who reached the 2.4 mg dose after a 20-week run-in | 68 weeks total | Continuing treatment: −7.9% (weeks 20 to 68); switching to placebo: +6.9% over the same period | Emerging (single trial funded by semaglutide's manufacturer) | 2021 | doi.org/10.1001/jama.2021.3224 |
| SELECT [8] | Double-blind, event-driven RCT, phase 3, funded by semaglutide's manufacturer | 17,604 | Adults age 45+, established cardiovascular disease, overweight or obesity, without diabetes | Mean follow-up 39.8 months | Cardiovascular death, heart attack or stroke, counted together: 6.5% (semaglutide) vs 8.0% (placebo); hazard ratio 0.80 | Emerging, for this population only (single trial funded by semaglutide's manufacturer) | 2023 | doi.org/10.1056/NEJMoa2307563 |
| SURMOUNT-5 (comparison trial) [9] | Open-label RCT, phase 3b, funded by tirzepatide's manufacturer | 751 | Adults with obesity, without type 2 diabetes | 72 weeks | Tirzepatide produced more weight loss than semaglutide (−20.2% vs −13.7%). In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, this was the largest randomized head-to-head trial with reported results that we found in adults with obesity and without type 2 diabetes. | Emerging | 2025 | doi.org/10.1056/NEJMoa2416394 |
In the STEP 1 extension, lifestyle support also stopped when treatment stopped, and participants were not randomized at withdrawal.
Evidence strength varies by claim. The STEP 1 weight-loss finding is treated as established evidence for adults without diabetes: STEP 1 was funded by semaglutide's manufacturer, but three independent reviews of placebo-controlled trials in adults without diabetes found consistent results [10][11][12]. One pooled 8 trials with 4,567 patients, and two pooled the same 4 trials with 3,613 participants; none of the three reports a certainty rating.
The SELECT heart finding is treated as emerging evidence, for its trial population only: SELECT is a single trial funded by semaglutide's manufacturer, and none of the four reviews whose abstracts we opened in searches of PubMed and Europe PMC on October 1, 2026, limited its pooled heart result to adults with established cardiovascular disease [13][14][15][16]. In searches of PubMed and Europe PMC on October 1, 2026, we found reviews that pooled heart outcomes from trials in broader groups of adults with overweight or obesity. They include a 2025 Cochrane review of semaglutide, funded by the World Health Organization [13], and two reviews that pooled trials of GLP-1 medicines as a group [14][15]. We read these reviews as abstracts only, and they are not yet reflected in this grade.
The two stopping-treatment trials, the STEP 1 extension and STEP 4, are also treated as emerging evidence: both were funded by semaglutide's manufacturer, and the one independent review we read that pooled them (6 studies with 8,993 patients overall, its semaglutide result drawn from 3 reports on STEP 4 and the STEP 1 extension) rated its own certainty in that result as low [17]. The SURMOUNT-5 head-to-head comparison against tirzepatide is treated as emerging evidence, not established: it is an open-label trial funded by tirzepatide's manufacturer [9]. In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, SURMOUNT-5 was the largest randomized head-to-head trial with reported results that we found in adults with obesity and without type 2 diabetes. In the same searches, a 2026 pilot study at one Italian university (La Vignera 2026, no external funding) assigned 90 adults with a body-mass index above 40 and no known diabetes at random to semaglutide or tirzepatide for six months. Across all participants it reported average weight loss of 10.2% with semaglutide and 11.8% with tirzepatide; its authors state that no formal inferential statistics were performed for its primary outcome, and they describe the study as observational and its findings as hypothesis-generating [18]. As of October 1, 2026, ClinicalTrials.gov lists each of the following randomized trials of semaglutide, tirzepatide and dulaglutide as completed, with no results posted: NCT07834398, in 150 adults without diabetes, and NCT07820111, in 159 adults with overweight or obesity, with and without diabetes. Zagazig University is the lead sponsor of both records [19][20].
SELECT's cardiovascular finding applies only to the trial population: adults aged 45 or older with established cardiovascular disease and overweight or obesity, who did not have diabetes. It does not show a heart benefit in people without established cardiovascular disease.
Potential benefits: What benefits are claimed, and which are supported?
In the 68-week STEP 1 trial, adults with obesity, or overweight plus a weight-related condition, and without diabetes lost about 15% of body weight on average on semaglutide 2.4 mg, versus about 2% on placebo, and results varied [5]. A separate finding applies only to a narrower group: in one trial funded by semaglutide's manufacturer (SELECT), in adults aged 45 or older with established cardiovascular disease and overweight or obesity, who did not have diabetes, semaglutide 2.4 mg reduced the combined risk of cardiovascular death, heart attack or stroke, counted together, by about 20% relative to placebo (6.5% vs 8.0% of participants over a mean of about 3.3 years) [8].
In the SELECT trial, which was funded by semaglutide's maker, 17,604 adults aged 45 or older with overweight or obesity and existing cardiovascular disease, but without diabetes, were randomly assigned to once-weekly semaglutide 2.4 mg or placebo, and death from any cause was the third of three secondary outcomes that the trial planned to test in a fixed order [8]. According to the SELECT paper, the first of the three, death from cardiovascular causes, did not reach the statistical threshold the trial required, so the other two, including death from any cause, were not formally tested [8]. The SELECT paper reports deaths from any cause in 375 of 8,803 people assigned to semaglutide (4.3%) and 458 of 8,801 assigned to placebo (5.2%), a hazard ratio of 0.81 (95% confidence interval 0.71 to 0.93), and says this interval, which was not adjusted for testing several outcomes, should not be used to infer a definite treatment effect [8]. The Wegovy prescribing information gives the same figures and says the result for death from any cause was not statistically significant under the trial's planned testing order [21].
In the Wegovy prescribing information's SELECT results, the hazard ratio for cardiovascular death alone was 0.85 (95% confidence interval 0.71 to 1.01), and the stroke result alone was not part of the trial's formal testing and its range included no difference (hazard ratio 0.89, 0.72 to 1.11) [1].
Among the benefits listed in this table, average weight loss in adults without diabetes is the only one graded established; the others are graded emerging, evidence against or not graded.
| Claimed benefit | Evidence level | Source |
|---|---|---|
| Average weight loss (~15% vs ~2% on placebo, 68 weeks, semaglutide 2.4 mg, adults with obesity or overweight plus a weight-related condition, without diabetes) | Established | STEP 1 (RCT) [5] |
| Lower combined risk of cardiovascular death, heart attack or stroke, counted together (6.5% vs 8.0%), in adults 45+ with established cardiovascular disease and overweight/obesity, without diabetes | Emerging, for this population only (single trial funded by semaglutide's manufacturer) | SELECT (RCT) [8] |
| More weight loss than tirzepatide | In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, the largest randomized head-to-head trial with reported results that we found in adults with obesity and without type 2 diabetes reported the opposite: tirzepatide −20.2% versus semaglutide −13.7% at 72 weeks. That finding is emerging (an open-label trial funded by tirzepatide's manufacturer). | SURMOUNT-5 (RCT) [9] |
| Slows aging, extends lifespan, improves "healthspan" | Not graded. In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no randomized trial with peer-reviewed or registry results from a planned test of whether semaglutide slows aging in people, and none that tested whether semaglutide extends lifespan in people without a diagnosed condition; the death-outcome trials we found are in people with named conditions. Not an approved use of any semaglutide product | Semaglutide for longevity |
| Treats or slows Alzheimer's disease | Evidence against: two large trials of oral semaglutide 14 mg (3,808 people aged 55 to 85 with early Alzheimer's disease, treatment up to 156 weeks) found it did not slow progression. In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no randomized trial with reported results that was designed to test whether semaglutide prevents dementia in people who do not have it. Not an approved use of any semaglutide product | evoke and evoke+ (RCTs) [22] |
Researchers are studying whether semaglutide affects aging, and in searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, the human results we found were analyses of lab markers of biological age (the peer-reviewed ones post hoc), which do not show how long or how well people live [23][24]. In searches of ClinicalTrials.gov, PubMed and Europe PMC on October 1, 2026, we found three registered randomized trials that include semaglutide and whose registry record or published protocol names markers of aging among the primary outcomes [25][26][27][28]. All three are small: one plans 66 adults with obesity, one plans 30 postmenopausal women aged 46 to 60 with obesity, and one, now complete, enrolled 20 adults aged 65 or older with prediabetes or type 2 diabetes [25][26][27]. All three trials are registered; none has reported results for its aging markers in ClinicalTrials.gov, PubMed or Europe PMC as of October 1, 2026, and the one completed trial has posted a single result, a change in lean body mass [27].
In a ClinicalTrials.gov search on October 1, 2026, we also found one registered randomized trial that compares low-dose semaglutide with placebo in adults aged 18 to 65 enrolled as healthy volunteers; it plans 150 participants, and the registry lists an industry sponsor [29]. That trial is registered; it has reported no results in ClinicalTrials.gov, PubMed or Europe PMC as of October 1, 2026, and its registered outcomes are pain, mood, sleep, physical activity, heart rate variability and routine blood tests, with no death or lifespan outcome [29].
In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no randomized trial that tested whether semaglutide lowers the risk of death or extends lifespan in people without a diagnosed condition. As of October 1, 2026, our ClinicalTrials.gov search found 19 registered randomized trials involving semaglutide that list death from any cause or time to death among their outcomes, and each is limited to people with a named condition, such as type 2 diabetes, cardiovascular disease, heart failure or chronic kidney disease. Six of those 19 trials list overweight or obesity among their conditions, and each of the six also requires another condition, such as existing cardiovascular disease, heart failure or atrial fibrillation.
Two large trials of oral semaglutide 14 mg, funded by semaglutide's manufacturer, found that it did not slow early Alzheimer's disease: 3,808 people aged 55 to 85 took part, treatment lasted up to 156 weeks, and the main measure was assessed at week 104 [22]. In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no randomized trial with reported results that was designed to test whether semaglutide prevents dementia in people who do not have it.
Limitations: What are the limits of the evidence?
The STEP 1 trial ran for 68 weeks in adults without diabetes, so it does not show results beyond 68 weeks or in people with diabetes [5]. SELECT enrolled only adults who already had established cardiovascular disease, so it does not show heart benefits in people without diagnosed cardiovascular disease [8].
SURMOUNT-5 was open-label, which means participants and researchers knew which medicine each person was taking, and it was funded by tirzepatide's manufacturer [9]. In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, SURMOUNT-5 was the largest randomized head-to-head trial with reported results that we found in adults with obesity and without type 2 diabetes. In the same searches, a 2026 pilot study at one Italian university (La Vignera 2026, no external funding) assigned 90 adults with a body-mass index above 40 and no known diabetes at random to semaglutide or tirzepatide for six months. Across all participants it reported average weight loss of 10.2% with semaglutide and 11.8% with tirzepatide; its authors state that no formal inferential statistics were performed for its primary outcome, and they describe the study as observational and its findings as hypothesis-generating [18]. As of October 1, 2026, ClinicalTrials.gov lists each of the following randomized trials of semaglutide, tirzepatide and dulaglutide as completed, with no results posted: NCT07834398, in 150 adults without diabetes, and NCT07820111, in 159 adults with overweight or obesity, with and without diabetes. Zagazig University is the lead sponsor of both records [19][20].
The STEP 1 weight figures describe results at week 68, the end of the treatment period; they do not describe what happens after treatment stops. In trials, people who stopped semaglutide regained, on average, much of the weight they had lost within about a year. The Wegovy label's weight results for its 68-week injection trial in 1,961 adults count all randomized participants, including people who stopped taking the medicine [1]. In that label trial, body weight at week 68 was missing for 7.2% of people randomized to Wegovy and 11.9% of those randomized to placebo, and the label says the missing values were imputed from retrieved subjects of the same randomized treatment arm [1].
According to the Wegovy prescribing information, semaglutide lowers body weight with greater fat mass loss than lean mass loss, so some of the weight lost is lean mass, not only fat [1]. Two reviews of randomized trials in adults with overweight, obesity or diabetes, one of 22 trials with 2,258 participants and one of 20 trials with 15,782 participants, estimated lean mass at roughly a quarter to over a third of the total weight lost on GLP-1 medicines, a share similar to that from lifestyle changes alone in one of the analyses [30][31]. We read only the abstracts of these reviews, and they did not state a certainty rating. The authors of a 2026 review of trials recommend resistance training, enough protein and body-composition monitoring, but the abstract we read did not show a trial that tested whether these protect muscle during GLP-1 treatment [31]. In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no published randomized trial of whether resistance exercise or added protein protects muscle during semaglutide treatment. Randomized trials designed to test this are registered on ClinicalTrials.gov; none of those we found had reported results in ClinicalTrials.gov, PubMed or Europe PMC as of October 1, 2026 [32].
Risks: What are the risks of semaglutide?
The prescribing information for each semaglutide product in the FDA status table carries a boxed warning about the risk of thyroid C-cell tumors. Wegovy injection carries a boxed warning about thyroid C-cell tumors seen in rodents. Wegovy tablets carry a boxed warning about thyroid C-cell tumors seen in rodents. A finding in rodents is not a human diagnosis, and unknown in humans is not the same as no risk.
The Wegovy prescribing information, which covers both Wegovy injection and Wegovy tablets, also warns about acute pancreatitis, gallbladder disease, low blood sugar (with a higher risk when taken with insulin or a sulfonylurea), kidney injury from dehydration, severe stomach and bowel reactions, serious allergic reactions, diabetic eye complications in people with type 2 diabetes, a faster heart rate, and inhaling stomach contents during anesthesia or deep sedation [1]. In Wegovy trials in adults for weight reduction, gallstones were reported by 1.6% of people on Wegovy injection and 0.7% of people on placebo [1]. In the SELECT trial, which was funded by semaglutide's manufacturer and enrolled adults aged 45 or older with established cardiovascular disease and overweight or obesity, without diabetes, 16.6% of people taking semaglutide 2.4 mg stopped treatment permanently because of an adverse event, compared with 8.2% on placebo, over a mean follow-up of about 3.3 years [8].
The European Medicines Agency's safety committee concluded in June 2025 that the eye condition NAION is a very rare side effect of semaglutide, meaning it may affect up to 1 in 10,000 people taking it. The conclusion rests on several large epidemiological studies in adults with type 2 diabetes, which suggest about one additional case of NAION per 10,000 person-years of treatment [33]. This is an EU regulator's conclusion from observational data, so it is treated as emerging evidence, and it covers semaglutide only. The agency advises anyone with sudden vision loss or rapidly worsening eyesight during treatment to contact a doctor without delay [33].
In January 2026, FDA requested removal of suicidal behavior and ideation warning language from the labels of Wegovy, Saxenda and Zepbound. FDA reviewed 91 placebo-controlled trials with 107,910 patients and a retrospective claims-data study of 2,243,138 people with type 2 diabetes who started a GLP-1 medicine or an SGLT2 inhibitor, and the results did not show an increased risk of suicidal thoughts or behavior or of other relevant psychiatric adverse events such as anxiety, depression, irritability or psychosis [34]. FDA advises patients to continue taking their medication as prescribed and to tell their health care professional about "new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior" [34].
Sources: Wegovy injection prescribing information, Revised 06/2026; Wegovy tablets prescribing information, Revised 06/2026; Ozempic injection prescribing information, Revised 05/2026; Ozempic tablets prescribing information, Revised 1/2026; Rybelsus tablets prescribing information, Revised 1/2026.
If you have severe symptoms, call 911 or seek emergency care. Report side effects to FDA MedWatch.
Side effects: What are the side effects of semaglutide?
The Wegovy label says stomach and bowel side effects were most frequently reported while the dose was being increased [1]. According to the Wegovy prescribing information, "adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice." [1] In the three pooled Wegovy 2.4 mg injection trials in adults with obesity or overweight, 19% of whom had type 2 diabetes, nausea was reported by 44% of people on Wegovy vs 16% on placebo, diarrhea by 30% vs 16%, vomiting by 24% vs 6%, and constipation by 24% vs 11% [1].
In the Wegovy 2.4 mg injection trials, 6.8% of people on Wegovy and 3.2% on placebo stopped treatment permanently because of side effects [1]. In the Wegovy label's weight-reduction trials in adults, 73% of people on Wegovy injection and 47% on placebo reported stomach and bowel side effects, including severe reactions in 4.1% of people on Wegovy injection and 0.9% on placebo [1].
Contraindication considerations: Who should not get semaglutide?
The Wegovy label, the Ozempic injection label, and the Rybelsus and Ozempic tablet label each list a personal or family history of medullary thyroid carcinoma (MTC), or MEN 2, or a prior serious allergic reaction to semaglutide or its ingredients, as a reason not to use semaglutide [1][2][3]. The Wegovy label advises stopping Wegovy at least 2 months before a planned pregnancy because semaglutide stays in the body for a long time [1]. Whether a product is appropriate for a specific person is decided by a licensed clinician using that product's prescribing information.
Sources: Wegovy injection prescribing information, Revised 06/2026; Wegovy tablets prescribing information, Revised 06/2026; Ozempic injection prescribing information, Revised 05/2026; Ozempic tablets prescribing information, Revised 1/2026; Rybelsus tablets prescribing information, Revised 1/2026.
Administration methods: How is semaglutide given?
Wegovy tablets are taken by mouth once a day, and Wegovy injection is given under the skin once a week [1]. The Wegovy label says Wegovy injection is given under the skin of the stomach area, thigh or upper arm, once a week on the same day each week [1]. The Wegovy label says patients are trained before the first injection and may then inject themselves if their healthcare provider determines it can be done properly, except that the Wegovy FlexTouch pen is not recommended for self-injection by people who are visually impaired [1].
The Wegovy injection label starts at 0.25 mg once weekly and raises the dose every 4 weeks, reaching 1.7 mg in weeks 13 through 16, with a maintenance dose from week 17 [1]. For a single missed dose, the Wegovy injection label says to take the dose as soon as possible if the next scheduled dose is more than 2 days away, and to skip it and resume on the regular day if the next dose is less than 2 days away [1]. If 2 or more consecutive doses are missed, the Wegovy label (Revised 06/2026, Section 2.4) says to "reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions." [1]
Dose schedules on this page summarize each product's prescribing information and are not instructions to follow. A prescriber sets and adjusts the dose.
Sources: prescribing information, Section 2 (Dosage and Administration), for Wegovy injection prescribing information, Revised 06/2026.
Typical appointment: What happens during a semaglutide appointment, and how long does it take?
In searches of PubMed and Europe PMC for clinical guidelines on obesity medicines on October 1, 2026, we found none that states how long a semaglutide visit takes; we opened four of the guidelines found and could not read two of them to the end. A 2015 Endocrine Society guideline on medicines for obesity suggests that everyone prescribed a weight-loss medicine be assessed for how well it is working and for safety at least monthly for the first 3 months, and at least every 3 months after that. The guideline rates this as a weak recommendation based on low-quality evidence [35]. It dates from before the STEP 1 trial of semaglutide was published in 2021, and it covers weight-loss medicines as a group. A licensed clinician considering semaglutide reviews your health history, including thyroid history, pancreatitis, gallbladder disease, pregnancy plans and other medicines.
FDA and regulatory status: Is semaglutide FDA-approved for weight loss?
Wegovy injection (under the skin) and Wegovy tablets (by mouth) are FDA-approved for weight management in certain people; Ozempic injection, Ozempic tablets and Rybelsus tablets are approved only for adults with type 2 diabetes (checked September 27, 2026).
Approved uses differ by semaglutide product.
The FDA status table lists each semaglutide product with its route and the uses in its prescribing information.
| Product | How it is given | What it's FDA-approved for | Prescribing information |
|---|---|---|---|
| Ozempic injection | given as an injection under the skin | Ozempic (semaglutide) injection, given under the skin, is FDA-approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes. It is also approved to lower the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, and to lower the risk of kidney function decline, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. It requires a prescription. Source: FDA prescribing information. | Ozempic injection prescribing information, Revised 05/2026 |
| Ozempic tablets | taken by mouth | Ozempic (semaglutide) tablets, taken by mouth, are FDA-approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes, and to lower the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk for these events. They require a prescription. Source: FDA prescribing information. | Ozempic tablets prescribing information, Revised 1/2026 |
| Rybelsus tablets | taken by mouth | Rybelsus (semaglutide) tablets, taken by mouth, are FDA-approved, along with diet and exercise, to improve blood sugar control in adults with type 2 diabetes, and to lower the risk of major cardiovascular events in adults with type 2 diabetes who are at high risk for these events. They require a prescription. Source: FDA prescribing information. FDA's shortage and discontinuation data list Rybelsus tablets as 'To Be Discontinued' (posted June 4, 2026). | Rybelsus tablets prescribing information, Revised 1/2026 |
| Wegovy injection | given as an injection under the skin | Wegovy (semaglutide) injection, given under the skin, is FDA-approved, with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term in adults and children 12 and older with obesity, and in adults with overweight who have at least one weight-related condition. It is also approved to lower the risk of major cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. It requires a prescription. Source: FDA prescribing information. Wegovy (semaglutide) injection, given under the skin, is FDA-approved, with a reduced-calorie diet and more physical activity, for noncirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) in adults under FDA's accelerated approval program, based on improvement of MASH and fibrosis. Continued approval may depend on a confirmatory trial. | Wegovy injection prescribing information, Revised 06/2026 |
| Wegovy tablets | taken by mouth | Wegovy (semaglutide) tablets, taken by mouth, are FDA-approved, with a reduced-calorie diet and more physical activity, to reduce excess body weight and keep it off long term in adults with obesity, or in adults with overweight who have at least one weight-related condition, and to lower the risk of major cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. Wegovy tablets are not approved for MASH or for children. They require a prescription. Source: FDA prescribing information. | Wegovy tablets prescribing information, Revised 06/2026 |
Uses outside the approved indications
Ozempic injection, Ozempic tablets and Rybelsus tablets are not FDA-approved for weight management. Their approved uses are listed in the FDA status table. Prescribing them for weight management is off-label. For weight management in certain people, together with a reduced-calorie diet and more physical activity, FDA has approved Wegovy injection, given under the skin, and Wegovy tablets, taken by mouth.
Semaglutide is not FDA-approved for anti-aging, longevity or general wellness. FDA has approved specific semaglutide products only for specific uses: Ozempic injection, Ozempic tablets and Rybelsus tablets for uses in adults with type 2 diabetes, and Wegovy injection and Wegovy tablets for lowering cardiovascular risk in adults with established cardiovascular disease and obesity or overweight, and for weight management in certain people (plus, for Wegovy injection only, MASH under accelerated approval). Using semaglutide for anti-aging or longevity is off-label. FDA has not reviewed whether it is safe and effective for that purpose.
Semaglutide is not FDA-approved for Alzheimer's disease. FDA has approved specific semaglutide products only for specific uses: Ozempic injection, Ozempic tablets and Rybelsus tablets for uses in adults with type 2 diabetes, and Wegovy injection and Wegovy tablets for lowering cardiovascular risk in adults with established cardiovascular disease and obesity or overweight, and for weight management in certain people (plus, for Wegovy injection only, MASH under accelerated approval). Using semaglutide for Alzheimer's disease is off-label. FDA has not reviewed whether it is safe and effective for that purpose.
Compounded semaglutide
Compounded semaglutide is a different product from Wegovy, Ozempic and Rybelsus.
On its page 'FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss' (FDA page content current as of October 1, 2026), FDA says that, as of May 31, 2026, it had received '990 reports of adverse events associated with compounded semaglutide.' FDA adds: 'It is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events.' FDA also says that federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA, 'so it is likely that adverse events from compounded versions of these drugs are underreported.' FDA further says: 'Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products.'
On its page 'FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss' (FDA page content current as of October 1, 2026), FDA says: 'FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products.' FDA also says: 'Additionally, the agency has received adverse event reports that may be related to patients prescribed compounded semaglutide or tirzepatide products in doses beyond what is in the FDA-approved drug label.'
Compounded semaglutide is not FDA-approved. FDA states: 'Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.' FDA determined that the shortage of semaglutide injection products was resolved on February 21, 2025, and said on April 1, 2026 that semaglutide was not on its drug shortage list.
Pending regulatory action
In a Federal Register notice published May 1, 2026, FDA proposed not to include semaglutide on the list of bulk drug substances that outsourcing facilities may use in compounding (the 503B Bulks List). As of October 1, 2026, we have not found a final decision.
Regulatory status checked September 27, 2026. Sources: www.accessdata.fda.gov/…/209637s038lbl.pdf; www.accessdata.fda.gov/…/213051Orig1s030lbl.pdf; www.accessdata.fda.gov/…/215256s025lbl.pdf; www.fda.gov/…/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize; public-inspection.federalregister.gov/…/2026-12937.pdf; www.fda.gov/…/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list; www.fda.gov/…/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss; www.fda.gov/…/compounding-and-fda-questions-and-answers; www.accessdata.fda.gov/…/218316Orig1s000ltr.pdf; www.accessdata.fda.gov/…/218316s007lbl.pdf
Prescription requirements: Do you need a prescription for semaglutide?
Each semaglutide product in the FDA status table is available only with a prescription (checked September 27, 2026). A licensed clinician decides whether semaglutide is appropriate for a specific person after reviewing their health history. Completing an intake form or making a payment does not guarantee a prescription.
Cost: How much does semaglutide cost for weight loss?
The cost of semaglutide can differ by product, dose, pharmacy and insurance plan. We have not yet collected dated, sourced prices for semaglutide, so this page shows no price. Compounded semaglutide is not FDA-approved. See FDA's statement.
Insurance: Does insurance cover semaglutide for weight loss?
Coverage varies by plan and can depend on the reason it is prescribed. Confirm coverage, and any prior authorization, with your insurer. Through the Medicare GLP-1 Bridge, a CMS program running from July 1, 2026 to December 31, 2027, eligible people with Medicare Part D coverage can get certain GLP-1 drugs, including Wegovy injection and Wegovy tablets, 'when used to reduce excess body weight and maintain weight reduction,' for a $50 monthly copay, with prior authorization (CMS, checked September 27, 2026).
Provider questions: What should you ask a provider before starting semaglutide?
- Based on my health history, which product and route do you recommend for me?
- Which parts of my health history, such as thyroid, pancreas or gallbladder problems or pregnancy plans, matter for this decision?
- How will you monitor my progress, and how often will we meet?
- Is the semaglutide you prescribe one of the products in the FDA status table, or a compounded version, and what does that difference mean for me?
Alternatives: What are the alternatives to semaglutide?
This page covers two options a reader may hear about besides semaglutide: compounded semaglutide and lifestyle-only programs.
| Alternative | Evidence and status | Source |
|---|---|---|
| Compounded semaglutide | In searches of PubMed, Europe PMC and ClinicalTrials.gov on October 1, 2026, we found no published randomized trial of a compounded semaglutide product. ClinicalTrials.gov lists a registered randomized trial that uses semaglutide prepared in a compounding base (NCT07092605); it had not reported results as of October 1, 2026 [29]. Compounded semaglutide is not FDA-approved. See FDA's statement. | FDA [36] |
| Lifestyle-only program (diet, exercise, behavioral support) | Lifestyle-only programs were not assessed as a stand-alone treatment for this page. In STEP 1, participants given the same lifestyle intervention plus placebo lost about 2% of body weight on average, compared with about 15% with semaglutide 2.4 mg at 68 weeks [5]. | STEP 1 [5] |
FAQs
How does semaglutide work for weight loss?
Semaglutide is a GLP-1 receptor agonist, and the Wegovy label says it delays gastric emptying. In the 68-week STEP 1 trial, adults with obesity, or overweight plus a weight-related condition, and without diabetes lost about 15% of body weight on average on semaglutide 2.4 mg, versus about 2% on placebo, and results varied. The STEP 1 results are trial averages, not a promise of the result for any one person.
How do you get a semaglutide prescription?
A licensed clinician decides whether semaglutide is appropriate for a specific person after reviewing their health history. You can connect with a licensed provider to ask about an evaluation. Completing an intake form or making a payment does not guarantee a prescription.
What happens when you stop semaglutide?
In two trials funded by semaglutide's manufacturer, people who stopped semaglutide regained, on average, about two-thirds of the weight they had lost within a year (STEP 1 extension) [6], while people who continued treatment lost further weight (STEP 4) [7]. The authors of the STEP 1 extension concluded that their findings "suggest ongoing treatment is required to maintain improvements in weight and health" [6]. A 2026 joint expert guidance statement from US obesity-care organizations (TOS, OMA and OAC) strongly recommends continuing obesity medicines during weight maintenance [37]. Whether and when to stop is a decision to make with your own clinician.
Next steps
Compounded semaglutide is not FDA-approved. See FDA's statement.
You can connect with a licensed provider to ask about an evaluation.
Find a Provider · Connect With a Licensed Provider A licensed clinician decides whether treatment is appropriate. A prescription is not guaranteed.
Related diagnostics and treatments
- Semaglutide side effects →
- Full FDA and regulatory status for semaglutide →
- Semaglutide products compared →
- Semaglutide tablets →
- Semaglutide for longevity →
- GLP-1 medication vs. bariatric surgery →
References
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