A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body Composition in Obese Participants

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.

Inclusion Criteria:

1. Voluntarily participate in the study and sign the Informed Consent Form (ICF);
2. Male or female participants aged between 18 and 75 years (inclusive) at the time of signing the ICF;
3. BMI ranging from 28.0 to 40.0 kg/m2 during the screening;
4. 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%;

Exclusion Criteria:

1. A clear diagnosis of type 1, type 2 diabetes or other types of diabetes (excluding gestational diabetes);

2. Screening criteria: Glycated hemoglobin ≥ 6.5% or fasting blood glucose ≥ 7.0 mmol/L.

   Obesity related:

3. Diagnosed with secondary obesity;

4. 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;

5. Uncontrolled thyroid disease, or screening criteria.