A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body Composition in Obese Participants
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
0
Recruiting sites
-
Estimated enrollment
60
Study population
Obesity / overweight
Eligibility highlights
•BMI 28-40
Primary endpoint
•Lean body mass
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
1 endpointSafety endpoint
Time frame:24 weeks
descriptive
Other (unclassified)
5 endpointsThe percentage change in lean body mass
Time frame:24 weeks
percent change from baseline, improvement
Effectiveness endpoint
Time frame:24 weeks
descriptive
Effectiveness endpoint
Time frame:24 weeks
descriptive
Effectiveness endpoint
Time frame:24 weeks
descriptive
Effectiveness endpoint
Time frame:24 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.