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A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
Plain-language guide to NCT06214741: phase 3 randomized trial of Survodutide, 307 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06214741
- Phase
- phase 3
- Status
- completed
- Start
- 2024-02-06
- Completion (planned or actual)
- 2025-07-29
- Participants
- 307 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Obesity; Overweight
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Survodutide.
This study in China is open to adults who are at least 18 years old who are living with overweight or obesity.
People with a body mass index (BMI) of 28 kg/m\^2 or higher or 24 kg/m\^2 or higher with at least 1 weight related problem can join the study.
It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
307 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: Male or female, age ≥18 years at the time of signing informed consent. Body mass index (BMI) ≥28 kg/m\^2 at screening, OR BMI ≥24 kg/m\^2 at screening with the presence of at least one of the following weight-related complications:. Obstructive sleep apnoea. Non-alcoholic steatohepatitis (NASH), as assessed in medical records by histological liver assessment (within the last 6 months). History of at least one self-reported unsuccessful dietary effort to lose body weight.
The full record lists 11 inclusion and 7 exclusion criteria; among the exclusions: treatment with any medication for the indication obesity within 3 months before screening; new initiation of any other glucose-lowering investigational drug within 3 months prior to screening for this trial.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Survodutide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Neither the participants nor the staff measuring them knew who was on Survodutide, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2024-02-06 with completion listed for 2025-07-29.
It ran at 28 sites in China (28).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Percentage change in body weight from baseline to Week 52 (time frame: At baseline and at Week 52).
It also tracked 20 secondary outcomes, for example Key secondary endpoint: Absolute change from baseline to Week 52 in waist circumference (cm), Absolute change from baseline to Week 52 in body weight (kg), Absolute change from baseline to Week 52 in glycosylated haemoglobin A1c (HbA1c) (%), Absolute change from baseline to Week 52 in HbA1c (mmol/mol), Absolute change from baseline to Week 52 in systolic blood pressure (SBP) (mmHg) and Absolute change from baseline to Week 52 in diastolic blood pressure (DBP) (mmHg).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Survodutide in 307 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Survodutide compound page, all human trials.
Our Notes on the Compound
Survodutide: An investigational long-acting GLP-1 and glucagon receptor dual agonist studied for obesity and metabolic liver disease.
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.