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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Obesity Adult Onset

In brief

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.

Key facts

Study ID

NCT07671391

Run by

Shanghai Zhongshan Hospital

People needed

60

Starts

2026-08-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%;

You may not qualify if…

• 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.
• Obesity related:
• 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;
• Uncontrolled thyroid disease, or screening criteria.

Full record on ClinicalTrials.gov

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