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A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body
Plain-language guide to NCT06492135: phase 1 non-randomized trial of Survodutide, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06492135
- Phase
- phase 1
- Status
- completed
- Start
- 2024-08-12
- Completion (planned or actual)
- 2025-04-15
- Participants
- 30 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Overweight; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Survodutide.
This study is open to Chinese adults aged 18 to 60 with overweight or obesity.
People can join the study if they have a Body Mass Index from 24 to 40.0 kg/m2.
Survodutide is a medicine being developed to help people with overweight or obesity.
It had two arms (groups): Arm 1: Participants with a body mass index (BMI) ranging from ≥27.0 kg/m² to ≤40.0 kg/m² (experimental) and Arm 2: Participants with a body mass index (BMI) ranging from ≥24.0 kg/m² to <27.0 kg/m² (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 30 actual participants took part.
It was open to people of any sex aged from 18 years up to 60 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age of 18 to 60 years. Obstructive sleep apnea. Further inclusion criteria apply.
The full record lists 10 inclusion and 9 exclusion criteria; among the exclusions: trial participants with the following laboratory findings at screening are excluded:; serum aspartate transaminase (ast) and/or alanine transaminase (alt) elevation ≥3× upper limit of normal (uln); total bilirubin ≥1.2× uln.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Survodutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2024-08-12 with completion listed for 2025-04-15.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): AUC0-168 (area under the concentration-time curve of survodutide in plasma over the time interval from 0 to 168h) (time frame: up to 7 days).
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Survodutide in 30 people.
Its size is small, so on its own it can only give an early look.
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.