---
title: "SURMOUNT-3: Tirzepatide Phase 3 Results | Primara Labs"
url: https://www.primaralabs.com/research/trials/surmount-3
source: Primara Labs, markdown mirror of the HTML page
---

# SURMOUNT-3

In SURMOUNT-3, a phase 3 trial of tirzepatide in adults with BMI of 30 or more, or 27 or more with at least one obesity-related complication (excluding diabetes), who achieved 5.0% or more weight reduction after a 12-week intensive lifestyle intervention (n=579), mean body weight changed by -18.4% on maximum tolerated dose (10 or 15 mg) over 72 weeks, against +2.5% on placebo (treatment-regimen estimand; Wadden TA et al. Nat Med 2023 (SURMOUNT-3)).

Primara Labs sells some of the compounds covered here. Every figure on this page links to its source and the date it was checked.

Updated 24 September 2026

Tirzepatide Explained: SURMOUNT, SURPASS and Philippines Status1:58·[Transcript and chapters](https://www.primaralabs.com/videos/tirzepatide)

## Results

Mean percent change in body weight by arm, as each source reports it. Navy bars are the trial arms, grey bars the comparator. Bars from different trials are not a head-to-head comparison: populations, durations and estimands differ.

## Side effects reported

In SURMOUNT-3, discontinuation because of adverse events was 10.5% on maximum tolerated dose (10 or 15 mg), against 2.1% on placebo. The most frequently reported adverse events were nausea in 39.7% on maximum tolerated dose (10 or 15 mg) against 14.0% on placebo, diarrhoea in 31.0% on maximum tolerated dose (10 or 15 mg) against 9.2% on placebo, constipation in 23.0% on maximum tolerated dose (10 or 15 mg) against 6.8% on placebo and vomiting in 18.1% on maximum tolerated dose (10 or 15 mg) against 1.4% on placebo.

| Event | Maximum tolerated dose (10 or 15 mg) | Placebo |
| --- | --- | --- |
| Discontinuation for adverse events | 10.5% | 2.1% |
| Nausea | 39.7% | 14.0% |
| Diarrhoea | 31.0% | 9.2% |
| Constipation | 23.0% | 6.8% |
| Vomiting | 18.1% | 1.4% |

Design

## Trial design and sources

Compound

Tirzepatide

Phase

3

Population

Adults with BMI of 30 or more, or 27 or more with at least one obesity-related complication (excluding diabetes), who achieved 5.0% or more weight reduction after a 12-week intensive lifestyle intervention

Participants randomised

579

Duration

72 weeks

Primary endpoint

Coprimary: additional mean percent weight change from randomization to week 72, and percentage achieving additional weight reduction of 5% or more

Estimand

treatment-regimen

Read out

15 October 2023

Enrolled participants who had lost 5% or more in a 12-week intensive lifestyle lead-in; figures are the additional change from randomisation. The placebo arm regained weight.

-   Wadden TA et al. Nat Med 2023 (SURMOUNT-3) [open](https://doi.org/10.1038/s41591-023-02597-w) · checked 23 September 2026
-   ClinicalTrials.gov NCT04657016 [open](https://clinicaltrials.gov/study/NCT04657016) · checked 23 September 2026
-   Registry: NCT04657016

Questions

## SURMOUNT-3, answered

### What did SURMOUNT-3 find?

In SURMOUNT-3, a phase 3 trial of tirzepatide in adults with BMI of 30 or more, or 27 or more with at least one obesity-related complication (excluding diabetes), who achieved 5.0% or more weight reduction after a 12-week intensive lifestyle intervention (n=579), mean body weight changed by -18.4% on maximum tolerated dose (10 or 15 mg) over 72 weeks, against +2.5% on placebo (treatment-regimen estimand; Wadden TA et al. Nat Med 2023 (SURMOUNT-3)).

### What side effects were reported in SURMOUNT-3?

In SURMOUNT-3, discontinuation because of adverse events was 10.5% on maximum tolerated dose (10 or 15 mg), against 2.1% on placebo. The most frequently reported adverse events were nausea in 39.7% on maximum tolerated dose (10 or 15 mg) against 14.0% on placebo, diarrhoea in 31.0% on maximum tolerated dose (10 or 15 mg) against 9.2% on placebo, constipation in 23.0% on maximum tolerated dose (10 or 15 mg) against 6.8% on placebo and vomiting in 18.1% on maximum tolerated dose (10 or 15 mg) against 1.4% on placebo.

Related

## More on tirzepatide

-   [TRIUMPH-5](https://www.primaralabs.com/research/trials/triumph-5)
-   [SURMOUNT-1](https://www.primaralabs.com/research/trials/surmount-1)
-   [SURMOUNT-2](https://www.primaralabs.com/research/trials/surmount-2)
-   [SURMOUNT-4](https://www.primaralabs.com/research/trials/surmount-4)
-   [SURMOUNT-5](https://www.primaralabs.com/research/trials/surmount-5)
-   [Evidence Map: Tirzepatide](https://www.primaralabs.com/research/evidence#tirzepatide)
-   [Tirzepatide 15mg](https://www.primaralabs.com/marketplace/tirzepatide-15mg)
