Actively Recruiting
Evaluate LAE102 in Healthy and Overweight/Obese Subjects
Led by Laekna Limited · Updated on 2026-01-09
160
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
CONDITIONS
Official Title
Evaluate LAE102 in Healthy and Overweight/Obese Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Male body weight at least 50 kg, female body weight at least 45 kg
- BMI between 18.5 and 28 for healthy participants (Parts A & B)
- BMI between 26 and 40 for overweight/obese participants (Part C)
- Negative test for human immunodeficiency virus antibody (HIV-Ab)
- Female participants with no childbearing potential or with serum hCG less than 5 mIU/mL if of childbearing potential
- Male participants agree not to donate sperm during the trial
- Willing to voluntarily participate and provide signed informed consent
- Agree to comply with scheduled visits, treatments, laboratory tests, and study procedures
You will not qualify if you...
- Significant abnormalities in vital signs, physical exam, ECG, or lab tests
- Allergy to the investigational drug or its components, or history of severe allergy
- Weight change over 5% in the 3 months before screening
- Diagnosed with secondary overweight or obesity
- Any significant medical conditions affecting safety or study results
- History of major diseases in various body systems or acute illnesses
- Positive for hepatitis B surface antigen, hepatitis C antibody, or syphilis antibody
- History or suspicion of substance abuse or positive drug screen
- Alcohol abuse within 1 year before screening or positive alcohol breath test
- Smoking more than 5 cigarettes per day in the last 3 months or unable to stop smoking during the study
- Vaccination within 30 days before screening or planned vaccination during the study
- Use of drugs (except allowed exceptions) within 14 days before first dose until study end
- Participation in another clinical trial with investigational product within 3 months prior
- Major surgery within 30 days before first dose or planned during study
- Blood donation or loss of 400 mL or more within 3 months before screening or blood transfusion
- Special dietary needs incompatible with study diet
- History of fainting or syncope
- Recent dieting or weight loss treatment within 30 days before first dose or major lifestyle changes
- Use of certain medications (GLP-1 receptor agonists, weight loss drugs, corticosteroids, psychiatric drugs) within 3 months before first dose (Part C)
- Regular muscle strength exercise (Part C)
- Any other condition deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 201203
Actively Recruiting
Research Team
L
Li Qiu, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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