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The 10 Tirzepatide Trials That Built the Case (2026)

Last verified August 2026 · 10 papers · every citation checked against PubMed

By Ruth Calder · Enforcement Editor
Editorially reviewed & fact-checked against primary sources · How we verify contentLast reviewed

Tirzepatide acts on two receptors rather than one, and the obvious question was whether that translates into anything a patient would notice. The SURMOUNT program answered it across six trials: obesity alone, obesity with diabetes, obesity after a lifestyle run-in, what withdrawal does, a direct comparison with semaglutide, and a Chinese population with lower baseline BMI. Around them sit three trials that matter for different reasons — sleep apnea, where it became the first drug of any kind approved for the condition; liver disease; and heart failure. SURPASS-2 is included last because it was a diabetes trial that produced the earliest hint of all of this, years before anyone ran it at obesity doses.

Ranked papers

#1SURMOUNT-1

Tirzepatide Once Weekly for the Treatment of Obesity

Jastreboff AM, Aronne LJ, Ahmad NN, et al. · N Engl J Med · 2022

What it measured: Body weight change at 72 weeks

The pivotal trial: 2,539 adults carrying obesity without diabetes, spread across three doses — 5, 10 and 15 mg — or placebo, over 72 weeks. The top dose delivered −20.9% against −3.1%, and about 57% of that arm shed a fifth or more of their starting weight — a figure no non-surgical treatment had produced before. It is the basis of Zepbound's November 2023 approval, and the number every subsequent obesity drug gets measured against.

PMID 35658024NCT04184622DOI 10.1056/NEJMoa2206038

#2SURMOUNT-2

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial

Garvey WT, Frias JP, Jastreboff AM, et al. · Lancet · 2023

What it measured: Body weight change at 72 weeks

938 adults who had both excess weight and type 2 diabetes, the population where these drugs reliably underperform. Tirzepatide managed −13.4% at 10 mg and −15.7% at 15 mg against −3.3%, with A1C down about 2.1 points. Roughly two-thirds of the effect seen without diabetes survives — a better retention than semaglutide manages, and the reason a diabetic patient may still be pointed at the weight-labeled product rather than the glycemic one.

PMID 37385275NCT04657003DOI 10.1016/S0140-6736(23)01200-X

#3SURMOUNT-3

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial

Wadden TA, Chao AM, Machineni S, et al. · Nat Med · 2023

What it measured: Weight change over 72 weeks, starting after a diet run-in

This one inverts the usual order. Participants first did 12 weeks of intensive diet and behavioral therapy, and only those who had already lost 5% were randomized. Adding tirzepatide from that starting point produced a further −18.4%, while the placebo group put 2.5% back on — bringing the total from original baseline to around 26%. Lifestyle work does not use up the drug's effect; it stacks with it.

PMID 37840095NCT04657016DOI 10.1038/s41591-023-02597-w

#4SURMOUNT-4

Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity: The SURMOUNT-4 Randomized Clinical Trial

Aronne LJ, Sattar N, Horn DB, et al. · JAMA · 2024

What it measured: Weight over the year after everyone had already lost about 21%

The withdrawal trial, and the numbers are stark. 670 people had already lost about 20.9% during a 36-week open-label run-in. Those who continued lost a further 5.5%. Those switched to placebo regained 14.0%. ⛔ Two-thirds of a very large weight loss, back within a year, in people who had done everything right. This is the single clearest piece of evidence that stopping is not a neutral act.

PMID 38078870NCT04660643DOI 10.1001/jama.2023.24945

#5SURMOUNT-5

Tirzepatide as Compared with Semaglutide for the Treatment of Obesity

Aronne LJ, Horn DB, le Roux CW, et al. · N Engl J Med · 2025

What it measured: Weight lost at 72 weeks, head to head against semaglutide

The trial everyone wanted: tirzepatide against semaglutide, head to head, at obesity doses, in 751 adults over 72 weeks. Tirzepatide produced −20.2% against −13.7% — a gap of 6.5 percentage points, or roughly half again as much weight lost. It is the strongest evidence available for choosing between the two, and it is why the ordering on our comparison pages goes the way it does.

PMID 40353578NCT05822830DOI 10.1056/NEJMoa2416394

#6SURMOUNT-CN

Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial

Zhao L, Cheng Z, Lu Y, et al. · JAMA · 2024

What it measured: Body weight change at week 52

210 Chinese adults given 10 mg, 15 mg or a placebo over a year, producing −13.6% and −17.5% against a placebo group that gained 2.3%. The point of the trial is the population: baseline BMI runs lower across much of Asia, and there was a genuine open question about whether these drugs would translate. They do, at effect sizes close to SURMOUNT-1's. It supported Lilly's 2024 filing in China.

PMID 38819983NCT05024032DOI 10.1001/jama.2024.9217

#7SURMOUNT-OSA

Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity

Malhotra A, Grunstein RR, Fietze I, et al. · N Engl J Med · 2024

What it measured: Breathing interruptions per hour of sleep, after a year

469 adults carrying obesity alongside moderate-to-severe obstructive sleep apnea, run as two trials — one in people using CPAP, one in people who were not. Tirzepatide cut apnea-hypopnea events by 25 to 29 an hour against 5 to 6 on placebo, better than halving the index, with 17 to 20% weight loss alongside. ★ This produced the December 2024 approval that made tirzepatide the first drug of any class licensed to treat sleep apnea, and it opened coverage arguments for people whose BMI alone would not qualify them.

PMID 38912654NCT05412004DOI 10.1056/NEJMoa2404881

#8SYNERGY-NASH

Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis

Loomba R, Hartman ML, Lawitz EJ, et al. · N Engl J Med · 2024

What it measured: Liver inflammation gone on biopsy at one year, with scarring no worse

190 patients whose MASH and stage F2 or F3 scarring had been confirmed by biopsy, assigned to 5, 10 or 15 mg against placebo across a year. Between 44% and 62% of the treated arms achieved resolution of the steatohepatitis without fibrosis worsening, against 10% on placebo, with 10 to 15% weight loss. ⚠ This is phase 2, on a biopsy endpoint, and phase 3 is still running — but it puts a second mechanism in play for a disease that had almost nothing five years ago.

PMID 38856224NCT04166773DOI 10.1056/NEJMoa2401943

#9SUMMIT

Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity

Packer M, Zile MR, Kramer CM, et al. · N Engl J Med · 2025

What it measured: Cardiac death or worsening heart failure, plus how patients rated their symptoms

731 patients carrying obesity alongside heart failure of the preserved-ejection-fraction type. Tirzepatide cut the combined risk of cardiovascular death or worsening heart failure by 38%, and improved symptom scores by 6.9 points more than placebo, alongside around 14% weight loss. Read alongside STEP-HFpEF for semaglutide, it makes obesity-related heart failure look like something these drugs treat rather than something they incidentally help.

PMID 39555826NCT04847557DOI 10.1056/NEJMoa2410027

#10SURPASS-2

Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes

Frías JP, Davies MJ, Rosenstock J, et al. · N Engl J Med · 2021

What it measured: Blood sugar control at 40 weeks — weight was a secondary measure

Included last because it came first. SURPASS-2 was designed to test blood sugar in 1,879 people with type 2 diabetes, and weight was a secondary measure — but over 40 weeks tirzepatide produced 7.6, 9.3 and 11.2 kg of loss at its three doses against 5.7 kg for semaglutide at 1 mg, while also controlling glucose better. It was the first randomized signal that hitting two receptors beats hitting one, years before SURMOUNT-5 confirmed it at the doses people actually take for weight.

PMID 34170647NCT03987919DOI 10.1056/NEJMoa2107519

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About this list

We curate ranked, citation-anchored PubMed paper lists for the most-searched questions in obesity medicine. Every citation on this page was checked against PubMed on 2026-08-16. Each paper card links directly to PubMed and to ClinicalTrials.gov where applicable.

Browse our full index of research lists or our long-form research articles.

See also: our tirzepatide overview page.