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A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)
Plain-language guide to NCT05024032: phase 3 randomized trial of Tirzepatide, 210 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05024032
- Phase
- phase 3
- Status
- completed
- Start
- 2021-09-01
- Completion (planned or actual)
- 2022-12-27
- Participants
- 210 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Obesity; Overweight; Metabolism and Nutrition Disorder
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Tirzepatide.
This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight.
The main purpose is to learn more about how tirzepatide affects body weight.
Participants received matching placebo SC QW.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 210 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease. Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: have diabetes mellitus; have a self-reported change in body weight \>5 kg within 3 months prior to screening; have obesity induced by other endocrinological disorders.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Tirzepatide group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.
Those kept unaware of assignments: participant and investigator.
It started in 2021-09-01 with completion listed for 2022-12-27.
It ran at 29 sites in China (29).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean Percent Change From Baseline in Body Weight (time frame: Baseline, Week 52).
It also tracked 19 secondary outcomes, for example Mean Change From Baseline in Body Weight, Mean Change From Baseline in Waist Circumference, Mean Change From Baseline in Absolute Body Weight, Mean Change From Baseline in Body Mass Index (BMI), Mean Change From Baseline in Hemoglobin A1c (HbA1c) and Mean Change From Baseline in Fasting Glucose (FSG).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Tirzepatide in 210 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.