Benefits and uses
Mounjaro benefits and uses
Mounjaro's FDA-reviewed benefits fall under two US uses: blood sugar control in type 2 diabetes, and a lower risk of major heart events in high-risk adults with type 2 diabetes.1 In five adult trials of 40 to 52 weeks, HbA1c fell about 1.7 to 2.4 points.1 Weight loss is not a US indication.1
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How to read these findings
Most Mounjaro findings below are measured outcomes from randomized trials, as FDA summarized them in the label.1 Each figure is a group average in people with type 2 diabetes taking 5 mg, 10 mg or 15 mg once weekly. It describes what a trial group showed, not what one person can expect, and the prescriber sets the dose under the label schedule.1
The evidence comes in three kinds:
- Phase 3 randomized trials: five adult SURPASS trials (475 to 2,002 adults each, 40 to 52 weeks), a trial in 99 children, and a heart outcomes trial of 13,299 adults.1
- Pharmacology studies: how the drug acts on insulin, glucagon and the stomach, as reported in the label.1
- Trials outside the label: studies of tirzepatide in other conditions, flagged as such on this page.
Approved uses
- Blood sugar in type 2 diabetes: with diet and exercise, in adults and children 10 and older.1
- Heart risk in type 2 diabetes: lowering the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults at high risk for these events, approved on August 27, 2026.12
- European Union: type 2 diabetes in adults, adolescents and children 10 and older, plus helping adults lose weight and keep it under control, with diet and physical activity.67
Weight loss is not among the US uses. FDA approved the same molecule for weight reduction under the name Zepbound.15
Blood sugar
Across the five adult SURPASS trials, HbA1c fell about 1.7 to 2.4 points over 40 to 52 weeks.1 In SURPASS-1, where Mounjaro was the only diabetes medicine, 78% to 85% of adults reached an HbA1c below 7%, against 23% on placebo.1 Three trials used an active comparator. Against semaglutide 1 mg, HbA1c fell 2.0 to 2.3 points against 1.9.1 Against daily basal insulin, it fell 1.9 to 2.1 points against 1.3 (degludec) and 2.1 to 2.4 points against 1.4 (glargine).1 The label's results tables mark all three Mounjaro doses as superior to each comparator.1 In children 10 and older, HbA1c fell 1.9 to 2.2 points over 30 weeks, against 0.2 on placebo.1 Trial by trial: Mounjaro and blood sugar.
Heart outcomes
SURPASS-CVOT randomized 13,299 adults with type 2 diabetes and established heart or blood vessel disease to Mounjaro (up to 15 mg) or dulaglutide 1.5 mg once weekly.1 Dulaglutide, the medicine in Trulicity, has its own approval to reduce cardiovascular risk in adults with type 2 diabetes, so Mounjaro was measured against an active drug rather than a placebo.41 Half of those given Mounjaro were 65 or older.1
| SURPASS-CVOT result | Mounjaro | Dulaglutide |
|---|---|---|
| First heart attack, stroke or cardiovascular death1 | 12.1% | 13.0% |
| Hazard ratio, 95.3% CI1 | 0.92 (0.83 to 1.01) | Reference |
| Death from any cause1 | 8.5% | 10.1% |
Over a median of 210.1 weeks, the main result met the test for non-inferiority but did not show superiority.1 The label counts all randomized and treated participants, 6,647 per group.1 The published trial report left out 134 people who did not meet entry criteria and counts 801 events (12.2%) against 862 (13.1%), with the same hazard ratio.3 The lower death rate (hazard ratio 0.84, 95% CI 0.75 to 0.94) was not controlled for multiple testing, so the label does not treat it as a confirmed finding.1 On the strength of this trial, FDA added the cardiovascular indication in August 2026.2
Weight in the diabetes trials
Weight was measured in every adult SURPASS trial, and people on Mounjaro lost about 5.4 to 11.3 kg over 40 to 52 weeks.1 In the two trials against daily basal insulin, people on insulin gained weight instead: 1.9 kg and 1.7 kg.1 These are diabetes trial results, not a weight indication.1 More on this: Mounjaro and weight loss.
How the effects arise
Tirzepatide activates the receptors for two natural hormones, GIP and GLP-1.1 Dulaglutide, its comparator in SURPASS-CVOT, is a GLP-1 receptor agonist.4 The label describes more insulin release and less glucagon, both in a glucose-dependent way, and slower stomach emptying.1
Results outside the label
Tirzepatide has also been studied, and approved as Zepbound, outside type 2 diabetes.5 Trials in heart failure and fatty liver disease are summarized in the questions on this page. The wider record is on Tirzepatide benefits and uses and Zepbound benefits and uses. None of these appears among Mounjaro's US uses.1
What the evidence does not show
- Superiority for heart events: Mounjaro was not shown to beat dulaglutide on the main heart outcome.1
- A confirmed survival benefit: the all-cause death result was not controlled for multiple testing.1
- Thyroid safety in humans: tirzepatide caused thyroid C-cell tumors in rats, and whether it does so in humans is unknown.1
- Results without side effects: stomach and gut effects affected 37.1% to 43.6% of adults on Mounjaro, against 20.4% on placebo.1 Full list: Mounjaro side effects.
Related pages
Back to the Mounjaro profile. Dose steps are on Mounjaro dosage, and pen handling on Mounjaro injection sites and pen use. The drug class as a whole is covered in GLP-1 benefits and uses.
More on Mounjaro
Mounjaro side effects
Side effects of Mounjaro as reported in labels, trials and published studies, with links to the full profile. Reviewed by a qualified reviewer.
Mounjaro dosage
Published dosing information for Mounjaro from labels and studies, with its source, and why it is not advice for you.
Mounjaro injection sites and pen use
Where Mounjaro is injected, how the pen is used, and site rotation, from the FDA label and Instructions for Use. Sourced and reviewed.
Frequently asked questions
What are the benefits and side effects of Mounjaro?
On the benefit side, HbA1c fell about 1.7 to 2.4 points in five adult trials, and since August 2026 the label includes lowering the risk of major heart events in high-risk adults with type 2 diabetes.12 Adults also lost about 5.4 to 11.3 kg in those trials, although weight loss is not a US indication.1 On the other side, stomach and gut effects lead: nausea affected 12% to 18% against 4% on placebo, mostly while the dose was rising.1 The boxed warning covers thyroid C-cell tumors seen in rats.1
Does Mounjaro have any heart benefits?
It has an approved heart-related use. Since August 27, 2026, the label covers lowering the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with type 2 diabetes at high risk.12 The evidence is SURPASS-CVOT, where 12.1% on Mounjaro and 13.0% on dulaglutide had such an event over a median of about four years.1 Mounjaro proved non-inferior to dulaglutide, a drug with its own cardiovascular indication, but it was not shown to be superior.14
What are the cons of taking Mounjaro?
The label lists several. Stomach and gut effects were common, and 3.0% to 6.6% of adults stopped treatment because of them, against 0.4% on placebo.1 Birth control pills may work less well, so the label advises a non-oral or added barrier method for 4 weeks after starting and after each dose increase.1 Low blood sugar becomes more likely when Mounjaro is combined with insulin or a sulfonylurea.1 The boxed warning covers thyroid C-cell tumors seen in rats, and Mounjaro is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2.1
Is Mounjaro used for heart failure or fatty liver disease?
Neither is an approved Mounjaro use in the US.1 Both have been studied with tirzepatide. In SUMMIT, a double-blind, placebo-controlled trial of 731 adults with heart failure with preserved ejection fraction and obesity, cardiovascular death or worsening heart failure occurred in 9.9% on tirzepatide against 15.3% on placebo.89 In SYNERGY-NASH, a 52-week phase 2 trial of 190 adults, the fatty liver disease MASH resolved without worse scarring in 44% to 62%, against 10% on placebo, and the authors called for larger, longer trials.13101112
Written by D2C Peptides Editorial Team.
Pending qualified review.
Updated .
Sources
- MOUNJARO (tirzepatide) injection Prescribing Information, Medication Guide and Instructions for Use, revised 08/2026 (NDA 215866/S-044, S-045). U.S. Food and Drug Administration (Drugs@FDA), 2026.
- FDA supplement approval letter, NDA 215866/S-044 and S-045 (Mounjaro), signed 08/27/2026. U.S. Food and Drug Administration, 2026.
- Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes (SURPASS-CVOT), PMID 41406444. New England Journal of Medicine (via NLM PubMed E-utilities), 2025.
- TRULICITY (dulaglutide) injection, prescribing information (revised 3/2026). U.S. National Library of Medicine, DailyMed (label by Eli Lilly), 2026.
- ZEPBOUND (tirzepatide) US Prescribing Information, revised 08/2026: Indications (weight). U.S. Food and Drug Administration (label for Eli Lilly and Company), 2026.
- Mounjaro: EPAR overview (type 2 diabetes). European Medicines Agency, 2026.
- Same source as 6: EPAR overview (weight).
- Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT), PMID 39555826: enrollment. New England Journal of Medicine (via NLM PubMed E-utilities), 2025.
- Same source as 8: SUMMIT abstract: primary outcome (PMID 39555826).
- Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis (SYNERGY-NASH), PMID 38856224: MASH resolution. New England Journal of Medicine (via NLM PubMed E-utilities), 2024.
- Same source as 10: SYNERGY-NASH abstract: 15 mg result (PMID 38856224).
- Same source as 10: SYNERGY-NASH abstract: conclusions (PMID 38856224).
- Same source as 10: SYNERGY-NASH abstract: participants (PMID 38856224).