RecruitingPhase 3NCT07481747

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

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)


Sponsor

Hudson Biotech

Enrollment

2,539 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (SURMOUNT-1) tests whether tirzepatide, a once-weekly injection, helps people who are overweight or obese safely lose weight over time. You may be eligible if... - Your BMI is 30 or higher, OR your BMI is 27 or higher with at least one weight-related health condition (e.g., high blood pressure, sleep apnea, heart disease) - You have tried and failed at least one diet effort to lose weight - You are 18 or older and able to self-inject or receive injections You may NOT be eligible if... - You have type 1 or type 2 diabetes, or lab results showing diabetes - Your weight has changed by more than 5 kg in the last 3 months - You have had or are planning bariatric (weight loss) surgery - You have severe kidney disease (eGFR below 30) - You have a history of pancreatitis, thyroid problems, or chronic stomach emptying issues - You have a serious psychiatric disorder or history of suicide attempt - Your obesity is caused by a hormonal condition like Cushing's syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

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

DRUGPlacebo

(once-weekly SC injection)

BEHAVIORALReduced-calorie diet

increased physical activity counseling


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07481747


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