Clinical trial

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

Opening soon · Phase 2 · 0 countries · Registry ID NCT07671391

Opening soonPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity Adult Onset

Full registry criteria

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.

Treatments and study arms

LAE102 +Tirzepatide

Drug

Receive LAE102, once a week, by subcutaneous injection.The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased every 4 weeks.

LAE102 placebo,+Tirzepatide

Drug

Receive the LAE102 placebo, once a week, by subcutaneous injection. The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased to a higher dose level every 4 weeks.

Primary outcomes

The percentage change in lean body mass24 weeks

At 24 weeks of treatment, the lean body mass measured by dual-energy X-ray absorptiometry (DXA) compared to the baseline percentage change

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.