FDA record · Obesity and weight management
What FDA's own documents say about Mounjaro: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
“MOUNJARO® is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.”
Prescribing information, supplement 052 · PDF p. 1 · fda.gov ↗
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| SURPASS-2I8F-MC-GPGL | NCT03987919 | 3 | 163 | 18 of 34 |
| SURPASS-118F-MC-GPGK | NCT03954834 | 3 | 148 | 18 of 34 |
| SURPASS-4I8F-MC-GPGM | NCT03730662 | 3 | 136 | 18 of 34 |
| MACE-4 | not given | 132 | 4 of 34 | |
| SURPASS-5I8F-MC-GPGI | NCT04039503 | 3 | 125 | 17 of 34 |
| SURPASS-3I8F-MC-GPGH | NCT03882970 | 3 | 114 | 16 of 34 |
| 16119 | NCT02759107 | 1 | 33 | 5 of 34 |
| 18F-MC-GPGB | NCT03131687 | 2 | 25 | 7 of 34 |
| SURPASS-CVOTI8F-MC-GPGN | NCT04255433 | 3 | 22 | 5 of 34 |
| SURPASS J-monoI8F-JE-GPGO | NCT03861052 | 3 | 18 | 5 of 34 |
| I8F-JE-GPGP | NCT03861039 | 3 | 17 | 5 of 34 |
| SURPASS-PEDSI8F-MC-GPGV | NCT05260021 | 3 | 12 | 6 of 34 |
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.
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
SURPASS-2 · HbA1c
“Except for a modest reduction in HbA1c reported in trial GPGL for subjects randomized to the tirzepatide 5 mg arm compared to the semaglutide 1 mg arm (comparator-subtracted reduction of -0.2%, 95% CI: -0.3, -0.0), the improvements in glycemic control for each tirzepatide dose arm were considered cl”
Clinical (Medical) Review · PDF p. 20 · fda.gov ↗
reduction of -0.295%
HbA1c
“Based on the Agency analysis of the primary efficacy endpoint (i.e., mean change in HbA1c from baseline to endpoint, treatmenteffect estimand), all three tirzepatide doses resulted in robust, statistically significant (all p<0.05 for superiority) reductions in HbA1c concentrations compared to the co”
Clinical (Medical) Review · PDF p. 108 · fda.gov ↗
p<0.05
BMI
“The interaction of dose with baseline pulse was nominally statistically significant for overall AS2 and non-Japan subgroups (p< 0.001 in both cases), and the interaction of BMI with dose was nominally statistically significant (p-value=0.047) for the Japan subgroup.”
Clinical (Medical) Review · PDF p. 158 · fda.gov ↗
p-value=0.047
body weights
“GLP-1 RA (i.e., dulaglutide), increases in pulse rate at Week 26 were less in Japanese subjects with lower (<70kg) vs. higher (270 kg) body weights (-0.92 bpm, 95% CI: -1.84, -0.00; p=0.05).19°”
Clinical (Medical) Review · PDF p. 157 · read by OCR · fda.gov ↗
95%p=0.05
“The most common adverse reactions, reported in >=5% of patients treated with MOUNJARO are nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.”
Prescribing information, supplement 052 · PDF p. 1 · fda.gov ↗
“Recommended Dosage: See prescribing information.”
Prescribing information, supplement 052 · PDF p. 40 · fda.gov ↗
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval215866s000lbl.pdf | May 13, 2022 | 28 | f56467e81bd7 | |
| Approval letter215866Orig1s000ltr.pdf | May 16, 2022 | 8 | 7de2f707034e | |
| Administrative Correspondence215866Orig1s000AdminCorres.pdf | June 15, 2022 | 52 | archived copy | ee74764dbb5d |
| Approval Letter215866Orig1s000Approv.pdf | June 15, 2022 | 11 | archived copy | 2c32e3506d08 |
| Chemistry Review215866Orig1s000ChemR.pdf | June 15, 2022 | 27 | ac3bd9a2e805 | |
| Clinical Pharmacology Review215866Orig1s000ClinPharmR.pdf | June 15, 2022 | 117 | 2c55bc893bd7 | |
| Prescribing Information (Label)215866Orig1s000Lbl.pdf | June 15, 2022 | 48 | 33b11f6ec48e | |
| Clinical (Medical) Review215866Orig1s000MedR.pdf | June 15, 2022 | 336 | archived copy | c83c51888190 |
| Proprietary Name Review215866Orig1s000NameR.pdf | June 15, 2022 | 20 | 6ef60db02cd5 | |
| Officer/Employee List215866Orig1s000OEList.pdf | June 15, 2022 | 3 | 59e9115db592 | |
| Other Reviews215866Orig1s000OtherR.pdf | June 15, 2022 | 206 | b158a10dad2c | |
| Pharmacology/Toxicology Review215866Orig1s000PharmR.pdf | June 15, 2022 | 51 | 695cd97686d7 | |
| Risk Assessment / REMS Review215866Orig1s000RiskR.pdf | June 15, 2022 | 16 | 78bdf5c6d521 | |
| Statistical Review215866Orig1s000StatR.pdf | June 15, 2022 | 121 | 3625ea791da9 | |
| Summary Review215866Orig1s000SumR.pdf | June 15, 2022 | 52 | 0d95c4385c28 | |
| Approval letter, supplements 002 and 006215866Orig1s002_s006ltr.pdf | July 31, 2023 | 5 | 579f9dc7e9db | |
| Prescribing information, supplements 002 and 006215866Orig1s002s006lbl.pdf | July 31, 2023 | 47 | dfa63c09e132 | |
| Approval letter, supplements 010 and 015 and 022215866Orig1s010_s015_s022ltr.pdf | November 5, 2024 | 5 | ac64d70f6f72 | |
| Prescribing information, supplements 010 and 015 and 022215866s010s015s022lbl.pdf | November 5, 2024 | 35 | eaa10e81160d | |
| Review, supplement 002215866Orig1s002.pdf | December 4, 2024 | 156 | 4229dd1c5689 | |
| Approval letter, supplement 031215866Orig1s031ltr.pdf | May 29, 2025 | 5 | 29eba634b83a | |
| Prescribing information, supplement 031215866s031lbl.pdf | June 2, 2025 | 35 | 7cd350d9a5ca | |
| Prescribing information, supplement 034215866s034lbl.pdf | September 26, 2025 | 35 | 5dd6e7ad6938 | |
| Approval letter, supplement 034215866Orig1s034ltr.pdf | September 26, 2025 | 4 | 810c9fda8df6 | |
| Prescribing information, supplement 039215866s039lbl.pdf | December 23, 2025 | 37 | b73c4b4c33ce | |
| Approval letter, supplement 039215866Orig1s039ltr.pdf | December 23, 2025 | 5 | ab54b8dbcc68 | |
| Prescribing information, supplement 041215866s041lbl.pdf | January 8, 2026 | 43 | 8f03807a9dd7 | |
| Approval letter, supplement 041215866Orig1s041ltr.pdf | January 8, 2026 | 4 | 3c6af513ff96 | |
| Prescribing information, supplement 009215866s009lbl.pdf | January 21, 2026 | 53 | dc1060de7793 | |
| Approval letter, supplement 009215866Orig1s009ltr.pdf | January 21, 2026 | 5 | 505aa0dd9907 | |
| 215866Orig1s045ltr, supplement 044215866Orig1s044_215866Orig1s045ltr.pdf | August 28, 2026 | 5 | 635d3938bf22 | |
| 217806Orig1s050ltr, supplement 052215866Orig1s052_217806Orig1s050ltr.pdf | September 1, 2026 | 5 | 62422a8c9692 | |
| Prescribing information, supplements 044 and 045215866s044s045lbl.pdf | September 1, 2026 | 55 | 2dd24413fff8 | |
| Prescribing information, supplement 052215866Orig1s052lbl.pdf | September 1, 2026 | 57 | d124868a5501 |
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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