Recruiting

SURMOUNT-1Tirzepatide Once Weekly for Weight Management in Obesity or Overweight with Comorbidities

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Study Aim

This study aims to evaluate the effectiveness of Tirzepatide, a once weekly treatment, in managing weight loss by measuring the percentage change in body weight and the proportion of participants achieving at least a 5% reduction in body weight.

What is being tested

Tirzepatide

+ Placebo

+ Reduced-calorie diet

DrugBehavioral
Who is being recruted

Body Weight+5

+ Nutrition Disorders

+ Nutritional and Metabolic Diseases

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2026
See protocol details

Summary

Principal SponsorHudson Biotech
Study ContactSeni S Lu, Phd
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 2, 2026

Actual date on which the first participant was enrolled.

This clinical trial focuses on the effectiveness and safety of a once-weekly drug called Tirzepatide in individuals without type 2 diabetes who are either obese or overweight and have health conditions related to their weight. The study's primary goal is to help these individuals manage their weight and potentially delay or prevent the onset of type 2 diabetes. Participants who have prediabetes at the start of the study can continue the treatment for a longer period to assess long-term weight management benefits. This research is crucial as it aims to provide a new treatment option for weight management and address the challenge of obesity-related health conditions. During the trial, participants are randomly assigned to receive one of four treatments: Tirzepatide in doses of 5 mg, 10 mg, 15 mg, or a placebo, which is a substance with no therapeutic effect. The drug is administered once a week via a subcutaneous injection using an autoinjector. All participants also receive lifestyle counseling that emphasizes a reduced-calorie diet and increased physical activity. The main treatment period lasts for 72 weeks. The study measures the mean percentage change in body weight from the start of the treatment and the percentage of participants who achieve a body weight reduction of 5% or more. Safety is monitored throughout the study, including any adverse events and laboratory testing.

Official TitleEfficacy 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)
Principal SponsorHudson Biotech
Study ContactSeni S Lu, Phd
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2539 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

5 inclusion criteria required to participate
BMI >= 30 kg/m^2, OR BMI >= 27 kg/m^2 with >= 1 weight-related comorbidity (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease)

History of at least one unsuccessful dietary effort to lose weight (self-reported)

Investigator judges participant capable and willing to self-inject (or have assistance), follow lifestyle advice, maintain a diary, and complete questionnaires

Age >= 18 years

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14 exclusion criteria prevent from participating
Type 1 or type 2 diabetes, history of ketoacidosis/hyperosmolar state, or screening labs diagnostic of diabetes

Recent significant weight change ( > 5 kg within 3 months prior to screening)

Prior/planned bariatric surgery; recent/ongoing endoscopic or device-based obesity therapies

Severe renal impairment (eGFR < 30 mL/min/1.73 m^2)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking University Shenzhen Hospital

Shenzhen, ChinaOpen Peking University Shenzhen Hospital in Google Maps
Recruiting
One Study Center
SURMOUNT-1 | Tirzepatide Once Weekly for Weight Management in Obesity or Overweight with Comorbidities | PatLynk