FDA drug record/Obesity and weight management/Wegovy

FDA record · Obesity and weight management

Wegovy (semaglutide)

What FDA's own documents say about Wegovy: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.

Sponsor
Novo
Application
NDA 215256
First approved
June 4, 2021
Status
Approved
Read from
44 FDA documents, 2,334 pages

What it is approved for

“WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity:”

218316s00lbl, supplement 031 · PDF p. 1 · fda.gov ↗

Trials FDA reviewed

TrialClinicalTrials.govPhaseMentionsDocuments
STEP 2NN9536-4374NCT03552757331524 of 44
WEGOVY 2not given30918 of 44
STEP 4NN9536-4376NCT03548987330322 of 44
SELECTNN9536-4388NCT03574597328816 of 44
STEP 1NN9536-4373NCT03548935324025 of 44
STEP 3NN9536-4375NCT03611582317722 of 44
WEGOVY 7not given1324 of 44
NN9536-4153NCT0245371121015 of 44
NN9536-4590NCT041873001266 of 44
STEP 5NN9536-4378NCT0369343032317 of 44
SUSTAIN 6NN9535-3744NCT017204463167 of 44
NN9535-3652NCT020643481134 of 44

Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.

Results FDA reported

Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.

body weight

“Those with the lowest body weight at baseline (randomization) lost more weight with semaglutide and p=0.0012 p=0.5356 p=0.3906 p<0.0001”

Clinical (Medical) Review · PDF p. 157 · fda.gov ↗

p=0.0012p=0.5356p=0.3906

MACE

“The hazard ratio (HR) (95% confidence interval (CI)) of time to first MACE was 0.80 (0.72, 0.90), p<0.0001. All”

Review, supplement 011 · PDF p. 67 · fda.gov ↗

p<0.0001

MACE

“The primary endpoint of time to first adjudicated MACE met the pre-specified Lan-DeMets stopping boundary of a 1-sided p-value < 0.00650 (based on 831 observed events) and furthermore met the applicant-defined decision boundary of a HR <= 0.80. The results were as follows:”

Review, supplement 011 · PDF p. 119 · fda.gov ↗

p-value < 0.00650

body weight

“The proportions of subjects on semaglutide 2.4 mg and placebo achieving 5% body weight loss were 86.4% and 31.5%, respectively, p < 0.0001.”

Clinical (Medical) Review · PDF p. 71 · fda.gov ↗

86.4%31.5%p < 0.0001

SUSTAIN 6 · MACE

“In the SUSTAIN 6 trial reviewed under NDA 209637,1 Ozempic (semaglutide in T2D) reduced the risk of MACE [HR 0.74 (0.58, 0.95), nominal p-value = 0.017 for superiority] compared to standard of care.”

Review, supplement 011 · PDF p. 68 · fda.gov ↗

p-value = 0.017

HbA1c

“HbA1c: -0.15% (-0.34, +0.04), p=0.1218”

Clinical (Medical) Review · PDF p. 101 · fda.gov ↗

-0.15%p=0.1218

Waist circumference

“Waist circumference: -2.69 cm (-3.72, -1.65), p<0.0001”

Clinical (Medical) Review · PDF p. 101 · fda.gov ↗

p<0.0001

Safety

Most common adverse reactions

“Most common adverse reactions (incidence >=5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and hair loss.”

218316s00lbl, supplement 031 · PDF p. 1 · fda.gov ↗

Adverse events the documents discuss most

Dosing on the label

“Follow the recommended dosage initiation and escalation in Table 1 for all indications to reduce the risk of gastrointestinal adverse reactions [see Warnings and Precautions (5.6), Adverse Reactions (6.1)].”

Prescribing information, supplement 023 · PDF p. 4 · fda.gov ↗

FDA documents read

DocumentDatePagesCopysha256
Prescribing information, original approval215256s000lbl.pdfJune 7, 20213488a3f908751f
Approval letter215256Orig1s000ltr.pdfJune 7, 20219bdb5c4c2907e
Administrative Correspondence215256Orig1s000AdminCorres.pdfDecember 27, 202155archived copycce3d3ac68fd
Approval Letter215256Orig1s000Approv.pdfDecember 27, 202112archived copycc43dcabd5be
Chemistry Review215256Orig1s000ChemR.pdfDecember 27, 202131ca4001ba3078
Clinical Pharmacology Review215256Orig1s000ClinPharmR.pdfDecember 27, 202140eb0d5c420418
Prescribing Information (Label)215256Orig1s000Lbl.pdfDecember 27, 202172f643f4fe34a3
Clinical (Medical) Review215256Orig1s000MedR.pdfDecember 27, 2021392886db858d085
Proprietary Name Review215256Orig1s000NameR.pdfDecember 27, 202120archived copy6de88111a570
Officer/Employee List215256Orig1s000OEList.pdfDecember 27, 20212archived copy6a5d8a019e65
Other Reviews215256Orig1s000OtherR.pdfDecember 27, 2021226d0cd1d661c40
Pharmacology/Toxicology Review215256Orig1s000PharmR.pdfDecember 27, 2021201112e1368360
Statistical Review215256Orig1s000StatR.pdfDecember 27, 202142b6b3a0136208
Summary Review215256Orig1s000SumR.pdfDecember 27, 202150ad028bb5fa67
Prescribing information, supplement 003215256s003lbl.pdfAugust 29, 2022342daffe92964b
Prescribing information, supplement 005215256s005lbl.pdfDecember 27, 202241fb6f28efb4ab
Approval letter, supplement 005215256Orig1s005ltr.pdfDecember 27, 20225a2b7eaeed33b
Prescribing information, supplement 006215256Orig1s006lbl.pdfFebruary 15, 2023105cb14162bfbf
Approval letter, supplement 006215256Orig1s006ltr.pdfFebruary 16, 202334bda81e765f9
Prescribing information, supplement 007215256s007lbl.pdfJuly 24, 20234395459bb5fc13
Approval letter, supplement 007215256Orig1s007ltr.pdfJuly 24, 20236507e814791e3
Prescribing information, supplement 011215256s011lbl.pdfMarch 8, 2024449d1bdbe513d9
Approval letter, supplement 011215256Orig1s011ltr.pdfMarch 11, 20245f11ad2023b9e
Review, supplement 011215256Orig1s011.pdfNovember 5, 20243002af837e26359
Prescribing information, supplement 021215256s021lbl.pdfNovember 5, 202445f2bc4d417ca3
Approval letter, supplement 021215256Orig1s021ltr.pdfNovember 5, 202459e84d429bb17
Approval letter, supplement 015215256Orig1s015ltr.pdfNovember 29, 2024588bc53a4eb93
Prescribing information, supplement 015215256s015lbl.pdfDecember 3, 2024447f7b6bc3b7af
Prescribing information, supplement 024215256s024lbl.pdfAugust 15, 202541552d67cc0ca5
Approval letter, supplement 024215256Orig1s024ltr.pdfAugust 18, 2025102da854666ec6
Prescribing information, supplement 026215256s026lbl.pdfOctober 15, 202548edd43e9a433d
Approval letter, supplement 026215256Orig1s026ltr.pdfOctober 15, 202559e587d3ae35d
Approval letter, supplement 023215256Orig1s023ltr.pdfNovember 24, 202543efacce13213
Prescribing information, supplement 023215256s023lbl.pdfNovember 25, 2025470b23c4e43461
Prescribing information, supplement 030215256s030lbl.pdfJanuary 29, 20265680c398a0f300
218316Orig1s002ltr, supplement 030215256Orig1s030_218316Orig1s002ltr.pdfJanuary 30, 20264e7bc25460bd0
218316Orig1s004ltr, supplement 033215256Orig1s033_218316Orig1s004ltr.pdfFebruary 27, 202647c1b3ceaacb7
Prescribing information, supplement 033215256s033lbl.pdfMarch 2, 2026563725e4079ebc
218316Orig1s005ltr, supplement 029215256Orig1s029_218316Orig1s005ltr.pdfMarch 23, 20268d7abb372b183
Prescribing information, supplement 025215256s025lbl.pdfJune 23, 202688cb3257c65ba1
Review, supplement 031215256Orig1s031.pdfAugust 7, 202620485a7ddfdccca
218316Orig1s005lbl, supplement 029215256Orig1s029_218316Orig1s005lbl.pdfAugust 24, 2026729d36c9c4a4fe
218316s00lbl, supplement 031215256s031_218316s00lbl.pdfSeptember 8, 202687a624215a150c
218316s00ltr, supplement 031215256s031_218316s00ltr.pdfSeptember 8, 202656a4c94be525c

Checked against FDA's copies on September 29, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.

Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.

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