Wegovy is an FDA-approved prescription product that contains semaglutide. Novo Nordisk markets it. Its label, the prescribing information published on DailyMed, reports the results of its clinical studies in section 14, and this guide reads that section.
Every fact below comes from the Wegovy label as published on DailyMed, updated June 18, 2026, and read through FDA's openFDA service on September 29, 2026, or from FDA's Drugs@FDA records read the same day. Quotes are word for word. The label prints the brand name in capital letters, and the quotes keep that. The label names its trials Study 1 to Study 11, each with a ClinicalTrials.gov number, and this page uses the label's names.
What this guide covers:
- What the Wegovy studies measured, and which of them this page reads
- The weight figures section 14 prints for adults, quoted with table number and date
- Whether everyone in the studies lost weight
- What the heart outcomes study reported, including what it did not confirm
- What the label says, and does not say, about how long Wegovy takes to work
- Which studies this page leaves out, and why
- What the results do not tell you about any one person
These results describe the FDA-approved product in its trials; they do not describe compounded preparations.
The label covers a Wegovy injection and a Wegovy tablet. This page reads only the injection studies named below. It does not reprint strengths, amounts or schedules; they belong to the label itself and to the physician who reads it with you.
What did the Wegovy clinical studies measure?
Section 14 of the label has four parts and eleven studies, and every study in it included a placebo group. The first part is about heart and blood vessel events, the second about weight in adults, the third about weight in adolescents and the fourth about a liver disease.
| Part of section 14 | Studies (label names) | What the part is about, in the label's terms | Read on this page? | Source and date |
|---|---|---|---|---|
| 14.1 | Study 1 (NCT03574597) | "Cardiovascular Outcomes Trial in Adult Patients with Cardiovascular Disease and Either Obesity or Overweight" | yes | label, section 14.1; read September 29, 2026 |
| 14.2 | Studies 2 to 9 | "Weight Reduction and Long-term Maintenance Studies in Adults with Obesity or Overweight" | Studies 2, 3 and 4 only | label, section 14.2; read September 29, 2026 |
| 14.3 | Study 10 | "Pediatric Patients Aged 12 Years and Older with Obesity" | no | label, section 14.3; read September 29, 2026 |
| 14.4 | Study 11 | "Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis with Moderate to Advanced Liver Fibrosis in Adults" | no | label, section 14.4; read September 29, 2026 |
The three weight studies this page reads are described in the label this way:
| Study (label name) | Who took part, in the label's terms | Source and date |
|---|---|---|
| Study 2 (NCT#03548935) | "Obesity or Overweight with Comorbidity"; people with type 2 diabetes were excluded | label, section 14.2, Table 8; read September 29, 2026 |
| Study 3 (NCT#03552757) | "Type 2 Diabetes with Obesity or Overweight" | label, section 14.2, Table 8; read September 29, 2026 |
| Study 4 (NCT#03611582) | "Obesity or Overweight with Comorbidity Undergoing Intensive Lifestyle Therapy"; people with type 2 diabetes were excluded | label, section 14.2, Table 8; read September 29, 2026 |
Section 14 of the Wegovy label names the primary measures of these three studies as "mean percent change in body weight and the percentages of patients achieving greater than or equal to 5% weight loss". In plain words: how much weight each group lost on average, and how many people reached a set amount.
Every group, placebo included, also followed a lifestyle program. For Studies 2 and 3, the label says that "all patients received instruction for a reduced-calorie diet" together with physical activity counseling. Study 4 went further: its people started with a low-calorie diet and then followed intensive lifestyle therapy, which is why the label's heading for it ends with "Undergoing Intensive Lifestyle Therapy".
How much weight did adults lose in the Wegovy studies?
Section 14 of the Wegovy label sums up Studies 2, 3 and 4 in one sentence: "After 68 weeks, treatment with WEGOVY injection resulted in a statistically significant reduction in body weight compared with placebo." Put simply, the groups taking Wegovy lost more weight on average than the groups taking placebo, and the difference passed the studies' statistical tests.
The table gives the average change that Table 8 of the label prints. The columns are the label's "PLACEBO" and "WEGOVY Injection". The label's title for Table 8 names a strength, so this page cites the table by its number only. A minus sign marks a decrease from the starting point, and "LSMean" is the label's abbreviation for "least squares mean", a type of statistical average.
| Study and measure (label wording) | Placebo | Wegovy injection | Source and date |
|---|---|---|---|
| Study 2, "Obesity or Overweight with Comorbidity": "% change from baseline (LSMean)" | "-2.4" | "-14.9" | label, section 14.2, Table 8; read September 29, 2026 |
| Study 3, "Type 2 Diabetes with Obesity or Overweight": "% change from baseline (LSMean)" | "-3.4" | "-9.6" | label, section 14.2, Table 8; read September 29, 2026 |
| Study 4, "Obesity or Overweight with Comorbidity Undergoing Intensive Lifestyle Therapy": "% change from baseline (LSMean)" | "-5.7" | "-16" | label, section 14.2, Table 8; read September 29, 2026 |
Each Wegovy figure should be read against the placebo figure of its own study. The three studies enrolled different people and used different lifestyle programs, so the label does not rank them against each other, and neither does this page.
These figures are group averages. Some people did not finish, and for some people the final weight was missing. The label explains how those gaps were handled: "Missing data were imputed from retrieved subjects of the same randomized treatment arm (RD-MI)." In plain words, a missing value was estimated from people in the same group who had stopped the study drug but still came back to be measured.
So does Wegovy work? In the label's terms, the question these studies answered was whether the groups taking Wegovy lost more weight on average than the groups taking placebo, and section 14 reports that they did. The label does not predict what will happen for any one person.
Did everyone in the studies lose weight?
The label does not say that everyone lost weight. Section 14 answers the question with shares: the percentage of people in each group who reached at least a set amount of weight reduction. The label measured the same shares in the placebo groups, and some people taking placebo reached each threshold too.
| Measure (label wording) | Placebo | Wegovy injection | Source and date |
|---|---|---|---|
| Study 2: "% of Patients losing greater than or equal to 5% body weight" | "31.1" | "83.5" | label, section 14.2, Table 8; read September 29, 2026 |
| Study 2: "% of Patients losing greater than or equal to 10% body weight" | "12" | "66.1" | label, section 14.2, Table 8; read September 29, 2026 |
| Study 2: "% of Patients losing greater than or equal to 15% body weight" | "4.8" | "47.9" | label, section 14.2, Table 8; read September 29, 2026 |
| Study 2: "% of Patients losing greater than or equal to 20% body weight", a row the label marks "Not included in the pre-specified hierarchical testing" | "1.7" | "30.2" | label, section 14.2, Table 8; read September 29, 2026 |
The note on the last row is a statistical qualifier: that comparison was not among those the studies planned in advance to test formally.
Each share describes a group, so none of them is the chance for one person. Section 14 of the Wegovy label also reports how many people stopped: "In Studies 2, 3, and 4, 16% of WEGOVY injection-treated patients and 19% of the placebo-treated patients discontinued therapy."
The label also looked at subgroups. The sentence in section 14 begins: "A reduction in body weight was observed with WEGOVY irrespective of age, sex, race, ethnicity, BMI at baseline" and goes on to name other starting traits. That sentence is about groups defined by those traits, not about each person.
What did the heart outcomes study report?
Section 1 of the label lists this as an approved use of Wegovy injection: "to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight." Study 1 is the trial behind that use.
Section 14 of the Wegovy label describes its size and design: "17,604 patients were randomized to WEGOVY injection or placebo", and "Patients with a history of type 1 or type 2 diabetes were excluded." The label defines what was counted: "The primary endpoint, MACE, was the time to first occurrence of a three-part composite outcome which included CV death, non-fatal myocardial infarction, and non-fatal stroke." MACE stands for major adverse cardiovascular events.
| Measure (label wording) | Placebo | Wegovy injection | Source and date |
|---|---|---|---|
| Study 1, "Primary composite endpoint", "Composite of CV death, non-fatal myocardial infarction, or non-fatal stroke": "Patients with events n (%)" | "701 (8%)" | "569 (6.5%)" | label, section 14.1, Table 6; read September 29, 2026 |
| Study 1, the same endpoint: "Hazard Ratio (95% CI)" | the comparison group | "0.8 (0.72; 0.9)" | label, section 14.1, Table 6; read September 29, 2026 |
A hazard ratio compares how often the events happened over time in the two groups, and a value below one means they happened less often in the Wegovy group. The label states the finding in one sentence: "WEGOVY injection significantly reduced the risk for first occurrence of MACE."
The label is just as clear about what the study did not confirm. A footnote to Table 6 says: "CV death was the first confirmatory secondary endpoint in the testing hierarchy and superiority was not confirmed." In plain words, the study was not able to confirm, by its own planned tests, that Wegovy lowered the risk of death from cardiovascular causes on its own. Another footnote adds: "Effect on heart failure has not been established."
The label also reports a subgroup sentence for this study: "The reduction of MACE with WEGOVY injection was not impacted by age, sex, race, ethnicity, BMI at baseline, or level of renal function impairment." As with the weight studies, that is a statement about groups, not a forecast for one person.
How long does it take for Wegovy to work, according to the label?
People often ask how long Wegovy takes to work. The label does not give a point at which Wegovy starts working for a person. It reports what each study measured at its end, and the studies were long. Studies 2, 3 and 4 were 68-week trials. The heart outcomes study counted events over its whole follow-up.
Section 14 also contains charts of the average change in body weight in each group over the course of the studies, such as Figure 7 for Studies 2 and 3. This page does not reprint values read off those charts. An average curve for a group does not tell any one person when a change will appear.
What the label does describe is how long semaglutide stays in the body. Section 12.3 of the Wegovy label begins one sentence "With an elimination half-life of approximately 1 week", and the rest of that sentence, which names a strength, is not reprinted here. Half-life describes how the body clears a drug. It is not a measure of when results appear. For more on clearance, see how long semaglutide stays in your system.
How a person is doing is reviewed by the prescriber at each visit. Questions about timing and progress belong in that conversation.
Which Wegovy studies does this page leave out, and why?
Section 14 prints results for more studies than this page reads. They are left out on purpose, and each one is in the label with the context a physician uses to read it:
- Study 5 is described in the label as a "randomized, double-blind, placebo withdrawal trial". It answered a different question, about what happened after some people stopped, and the label itself warns that its "results may not reflect the experience of patients in the general population who are first starting WEGOVY injection." Read it in section 14.2.
- Studies 6, 8 and 9 compare study groups that differ in strength, and this page does not reprint strengths. Read them in section 14.2.
- Study 7 is the study of the Wegovy tablet, and its study group is also defined by strength. Read it in section 14.2.
- Study 10 enrolled adolescents. Read it in section 14.3.
- Study 11 is the liver study behind a use that section 1 says "is approved under accelerated approval based on improvement of MASH and fibrosis". Read it in section 14.4.
The label's table of waist size, blood pressure, cholesterol and other cardiometabolic measures from the heart outcomes study is not reprinted either.
Do these results apply outside the trials?
Section 14 describes the FDA-approved Wegovy product in its own trials. Those trials had entry rules, a lifestyle program for every group and a fixed length. The label does not say what any one person outside them will see.
Some limits come straight from the label:
- Studies 2 and 4 left out people with type 2 diabetes; for each, the label says "patients with type 2 diabetes mellitus were excluded". The heart outcomes study left out people with type 1 or type 2 diabetes.
- The studies this page reads enrolled adults.
- The results come with a lifestyle program, because section 1 pairs Wegovy injection with "a reduced calorie diet and increased physical activity".
The label also reports side effects in its own sections, 5 and 6. For how semaglutide acts in the body, see the science behind GLP-1 and semaglutide. For how Wegovy compares with an older product in the same class, see Saxenda vs Wegovy.
Who decides whether Wegovy is appropriate?
A licensed physician does. The prescribing information is written for health care professionals, and Wegovy also comes with a Medication Guide written for patients. Medication is prescribed only if a licensed physician determines it is appropriate, and the answer can be no.
Useful questions for that conversation:
- Does section 1 of the label describe my situation?
- Does the boxed warning, titled "WARNING: RISK OF THYROID C-CELL TUMORS", or anything in section 4 apply to me or my family history?
- Which warnings in section 5 matter for my health history?
- How will we judge whether it is working for me, and what will we review at each visit?
- I take other medicines. Does anything in the label apply to them?
Where can you read section 14 yourself?
The label is public and free to read.
- Open DailyMed, the National Library of Medicine's label library, and search for Wegovy.
- Check the set id: ee06186f-2aa3-4990-a760-757579d8f77b.
- Note the "updated" date on the page. On September 29, 2026, DailyMed showed June 18, 2026.
- Scroll to section 14, "Clinical Studies", and read Table 6 and Table 8 with the footnotes under each.
- For the approval history, search Drugs@FDA for NDA 215256, the injection, and NDA 218316, the tablet.
For help with the layout of a label, see how to read a prescription label.
What the primary sources say
- Novo Nordisk via DailyMed, Wegovy (semaglutide) prescribing information, set id ee06186f-2aa3-4990-a760-757579d8f77b, updated June 18, 2026 (accessed September 29, 2026): "After 68 weeks, treatment with WEGOVY injection resulted in a statistically significant reduction in body weight compared with placebo."; "WEGOVY injection significantly reduced the risk for first occurrence of MACE."; "CV death was the first confirmatory secondary endpoint in the testing hierarchy and superiority was not confirmed."; "Effect on heart failure has not been established."
- U.S. Food and Drug Administration, openFDA drug label API, Wegovy label version 19, effective June 18, 2026 (accessed September 29, 2026): the same label text, word for word, including section 14, "CLINICAL STUDIES", with Table 6 and Table 8; the trials are named "Study 1" to "Study 11" with ClinicalTrials.gov numbers.
- U.S. Food and Drug Administration, Drugs@FDA application data through openFDA, NDA 215256 and NDA 218316 (accessed September 29, 2026): Wegovy, sponsor "NOVO"; the original application (ORIG) of NDA 215256, the injection, carries status "AP" dated "20210604", and that of NDA 218316, the tablet, status "AP" dated "20251222".
Every source is listed with its address below.
This article is for informational purposes only and does not constitute medical advice. Medication is prescribed only if a licensed physician determines it is appropriate. Label sentences and figures are quoted word for word from the FDA-approved prescribing information named above, as published on DailyMed on the date shown. Labels change, so read the current label and the Medication Guide that came with your own medicine.
Frequently Asked Questions
Does Wegovy work?
Section 14 of the label reports that in the adult weight studies it reads, the groups taking Wegovy injection had a statistically significant reduction in body weight compared with the groups taking placebo. That is a statement about study groups, not a promise for any one person. Whether Wegovy is appropriate for a specific person is a decision for a licensed physician.
How long does it take for Wegovy to work?
The label does not give a point at which Wegovy starts working for a person. It reports what each study measured at its end and shows the average course of each study group in charts. How a person is doing is reviewed by the prescriber at each visit.
Did everyone in the Wegovy studies lose weight?
The label does not say that. It reports averages for each group and the share of people in each group who reached set amounts of weight reduction. It also reports that some people in both the Wegovy and placebo groups stopped the study drug before the end.
Does Wegovy lower the risk of heart attack and stroke?
Section 1 of the label lists reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight as an approved use of Wegovy injection, and section 14 reports the study behind it. Whether that use applies to a specific person is a decision for a licensed physician.
Did the heart study show that Wegovy lowers the risk of cardiovascular death?
No. A footnote in section 14 says cardiovascular death was the first confirmatory secondary endpoint and that superiority was not confirmed. The label also says an effect on heart failure has not been established.
Do these results apply to other semaglutide products?
The results in section 14 describe the FDA-approved Wegovy product in its own trials, with the people and lifestyle programs those trials used. They do not describe any other product. Other products that contain semaglutide are separate products, and the trials in this label did not study them.
Why does this page leave out some of the label's figures?
The page does not reprint strengths, amounts or schedules, the withdrawal study, the studies whose groups differ by strength, the tablet study, the adolescent study, the liver study, or the table of cardiometabolic measures. All of them are in the label, where they sit next to the context a physician uses to read them.
Who decides whether Wegovy is appropriate for me?
A licensed physician decides, after reviewing your health history and the label. Medication is prescribed only if a licensed physician determines it is appropriate, and the answer can be no.
Sources
This article is based on the following primary sources. Links open the original documents.
- 1.Wegovy (semaglutide) prescribing information, DailyMed set id ee06186f-2aa3-4990-a760-757579d8f77b (updated June 18, 2026) · Novo Nordisk via DailyMed, U.S. National Library of Medicine · accessed
- 2.openFDA drug label API: Wegovy label by set id (full label text, version 19, effective June 18, 2026) · U.S. Food and Drug Administration (openFDA) · accessed
- 3.openFDA Drugs@FDA API: application NDA215256 (Wegovy injection, original approval date) · U.S. Food and Drug Administration (openFDA) · accessed
- 4.openFDA Drugs@FDA API: application NDA218316 (Wegovy tablet, original approval date) · U.S. Food and Drug Administration (openFDA) · accessed
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- Written against primary sources: FDA labeling and safety communications, NIH and CDC publications, state statutes and medical board rules
- Documented compliance review against FDA, FTC and LegitScript requirements before publication
- External sources, where an article cites them, are listed at the end of that article with links to the original documents
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