Efficacy and Safety of Liraglutide on Body Weight in Obese Subjects or Overweight Subjects With C… (NCT04487743) | Clinical Trial Compass
UnknownPhase 3
Efficacy and Safety of Liraglutide on Body Weight in Obese Subjects or Overweight Subjects With Co-morbidities
China300 participantsStarted 2020-05-09
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 safety, tolerability 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
Mean Change From Baseline in Fasting Body Weight
Timeframe: Week 0, Week 28
2
Percentage of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
Timeframe: Week 28
Trial details
NCT IDNCT04487743
SponsorXiangya Hospital of Central South University