Gut Microbiome Changes Following Liraglutide Treatment in Obese Subjects or Overweight Subjects With Co-morbidities
NCT04525300 · Unknown status
Last updated 2026-05-28This clinical trial studies how the gut microbiome changes in adults with obesity or overweight conditions with related health issues after receiving the medication liraglutide.
What this study is testing ClinicalTrials.gov NCT04525300 ↗
Description as written by the study sponsor.
We performed a multicenter, randomized, double-blind, placebo-controlled 28-week trial. 300 non-diabetic obese subjects or overweight subjects with co-morbidities were randomly assigned. Eligible participants were randomized 2:1 to once-daily subcutaneous injections of either liraglutide or placebo. The primary outcome is to investigate the composition of the gut microbiota from baseline to end of treatment.
Treatments tested
- Liraglutide also known as S20200402 Drug
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
- placebo also known as S20200301 Drug
Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
| Main thing measured | The composition of the gut microbiota from baseline to end of treatment. |
|---|---|
| Sponsor | Xiangya Hospital of Central South University |
| Conditions studied | Obesity |
| GLP-1 drugs | liraglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04525300 ↗