SURMOUNT-1Tirzepatide Once Weekly for Weight Management in Obesity or Overweight with Comorbidities
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.
Tirzepatide
+ Placebo
+ Reduced-calorie diet
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2539 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalStudy 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
Peking University Shenzhen Hospital
Shenzhen, ChinaOpen Peking University Shenzhen Hospital in Google Maps