A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LAE102 +Tirzepatide, LAE102 placebo,+Tirzepatide.
- Who it may be relevant to
- Registry conditions: Obesity Adult Onset. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body Composition in Obese Participants
Overview
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 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. - Drug LAE102 placebo,+Tirzepatide
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 outcome measures
- The percentage change in lean body mass [Time frame: 24 weeks]
Secondary outcome measures (5)
- Effectiveness endpoint [Time frame: 24 weeks]
- Effectiveness endpoint [Time frame: 24 weeks]
- Effectiveness endpoint [Time frame: 24 weeks]
- Effectiveness endpoint [Time frame: 24 weeks]
- Safety endpoint [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- 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%;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07671391 · ZSJZ2026