DRUG
LAE102 +Tirzepatide
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.
Status
Not yet recruiting
Phase
Phase 2
Enrollment
60
Locations
0
Results
Not posted
Publications
0
Study summary
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.
Interventions
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.
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.
Timeline
First posted
Jun 26, 2026
Study start
Aug 2026
Primary completion
Jul 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Jun 26, 2026
Outcomes
The percentage change in lean body mass
Time frame · 24 weeks
At 24 weeks of treatment, the lean body mass measured by dual-energy X-ray absorptiometry (DXA) compared to the baseline percentage change
Effectiveness endpoint
Time frame · 24 weeks
The change in weight at 24 weeks compared to the baseline and the corresponding percentage
Effectiveness endpoint
Time frame · 24 weeks
Change in lean body mass from baseline at 24 weeks of treatment
Effectiveness endpoint
Time frame · 24 weeks
Change and percentage of fat mass at 24 weeks of treatment
Effectiveness endpoint
Time frame · 24 weeks
Changes and percentage of lean body mass in limbs at 24 weeks of treatment
Safety endpoint
Time frame · 24 weeks
Numbers of adverse events during treatment (TEAE)
Eligibility
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.
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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