Gut Microbiome Changes Following Liraglutide Treatment in Obese Subjects or Overweight Subjects W… (NCT04525300) | Clinical Trial Compass
UnknownPhase 3
Gut Microbiome Changes Following Liraglutide Treatment in Obese Subjects or Overweight Subjects With Co-morbidities
China300 participantsStarted 2020-05-24
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Informed consent obtained before any trial-related activity takes place
* Obesity (BMI ≥30.0 kg/m2); or overweight (BMI ≥27.0 kg/m2) with treated or untreated co-morbid dyslipidemia (Low-density lipoprotein ≥3.38mmol/l (130 mg/dl), or triglycerides ≥1.7mmol/l (150 mg/dl), or high-density lipoprotein \<1.04mmol/l (40 mg/dl) for males and \<1.30mmol/l (50 mg/dl) for females) and/or hypertension (Systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
* Age ≥18 years, ≤75 years
Exclusion Criteria:
* Diagnosis of type 1 or type 2 diabetes per the judgment of the investigator
* HbA1c ≥6.5% or fasting plasma glucose ≥7.0 mmol/l or 2-hour post-challenge plasma glucose ≥11.1 mmol/liter (at screening)
* less than 5 kg self-reported change during the previous 3 months
* Previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide) within the last 3 months
* Known or suspected hypersensitivity to trial product, related products or other GLP-1 receptor agonist
* Diet attempts using herbal supplements or over-the-counter medications within 1 months before screening, or use prescription drugs for weight loss within 3 months before screening (for example: orlistat, fenfluramine, maindole ) Or lipid dissolving injection (for example: lipolysis needle) treatment
* Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (more th…
What they're measuring
1
The composition of the gut microbiota from baseline to end of treatment.
Timeframe: week 28
Trial details
NCT IDNCT04525300
SponsorXiangya Hospital of Central South University