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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
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.
The percentage change in lean body mass
At 24 weeks of treatment, the lean body mass measured by dual-energy X-ray absorptiometry (DXA) compared to the baseline percentage change
Time frame: 24 weeks
Effectiveness endpoint
The change in weight at 24 weeks compared to the baseline and the corresponding percentage
Time frame: 24 weeks
Effectiveness endpoint
Change in lean body mass from baseline at 24 weeks of treatment
Time frame: 24 weeks
Effectiveness endpoint
Change and percentage of fat mass at 24 weeks of treatment
Time frame: 24 weeks
Effectiveness endpoint
Changes and percentage of lean body mass in limbs at 24 weeks of treatment
Time frame: 24 weeks
Safety endpoint
Numbers of adverse events during treatment (TEAE)
Time frame: 24 weeks
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