Gut Microbiome Changes Following Liraglutide Treatment in Obese Subjects or Overweight Subjects With Co-morbidities

Sponsor
Xiangya Hospital of Central South University
Study ID
NCT04525300
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — 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 — 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

Study Details

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.

Key Dates

Start date
May 24, 2020
Status verified
Aug 2020
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    Subject receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.
  • Placebo Comparator: placebo
    Subject receiving placebo 3.0 mg subcutaneous (under the skin) injection once daily for 28 weeks.

Primary Outcome Measure

The composition of the gut microbiota from baseline to end of treatment. [ Time Frame: week 28 ]

Central Contacts

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