About this trial
This study is a randomized, double-blind, placebo-controlled trial aimed at exploring the effects of LAE102 injection in combination with Tirzepatide on body composition.
Eligibility criteria
Qualifiers
Voluntarily participate in the study and sign the Informed Consent Form (ICF);
Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF;
BMI ranging from 28.0 to 40.0 kg/m2 during the screening;
Self-reporting at least one experience of weight loss failure after adjusting diet and exercise, and within the previous 3 months, the weight change after only dietary and exercise adjustments was less than 5%;
Disqualifiers
A clear diagnosis of type 1, type 2 diabetes or other types of diabetes (excluding gestational diabetes);
Screening criteria: Glycated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L.
Diagnosed with secondary obesity;
Previously underwent surgical or endoscopic weight loss metabolic surgery (except for local liposuction within 1 year before screening) or gastric balloon implantation, or planned to undergo any weight loss surgery or receive other weight loss treatments during the study;
Trial design
Treatments tested in this trial
- LAE102 +Tirzepatide
- LAE102 placebo,+Tirzepatide