Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)

NCT07481747 · Recruiting

Last updated 2026-05-28

This clinical trial tests whether a once-weekly injection of tirzepatide reduces body weight in adults who are obese or overweight with weight-related health issues, compared to a placebo.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 2,539 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2026-02 · est. completion 2028-03

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT07481747 ↗

Description as written by the study sponsor.

This Phase 3 study evaluates the efficacy and safety of once-weekly subcutaneous tirzepatide (a dual GIP and GLP-1 receptor agonist) at 5 mg, 10 mg, or 15 mg versus placebo, each used with a reduced-calorie diet and increased physical activity, in adults without type 2 diabetes who have obesity or are overweight with weight-related comorbidities. The primary efficacy assessment is at Week 72. Participants with prediabetes at randomization may continue in an additional long-term treatment period to assess progression to type 2 diabetes and longer-term weight outcomes.

Treatments tested

Tirzepatide Drug

(once-weekly SC injection; doses 5/10/15 mg)
Placebo Drug

(once-weekly SC injection)
Reduced-calorie diet Behavioral

increased physical activity counseling

Main thing measured	Mean percent change in body weight from randomization
Sponsor	Hudson Biotech
Conditions studied	Obesity, Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07481747 ↗