Actively Recruiting
A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants
Led by Laekna Limited · Updated on 2026-01-20
104
Participants Needed
1
Research Sites
115 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 LAE103 injection in healthy overweight/obese participants or healthy postmenopausal women. Study will also evaluate the safety, tolerability and preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants. In addition, the study will also investigate the safety, tolerability of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants.
CONDITIONS
Official Title
A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and follow study requirements
- Male or female aged 18 to 55 years for parts A, C, D
- Female aged 45 to 75 years for part B
- Body mass index (BMI) 25.0 to 40.0 kg/m2 for parts A, C, D
- BMI 20.0 to 35.0 kg/m2 for part B
- Participants without childbearing potential or non-pregnant, non-lactating women who agree to use two forms of contraception (one highly effective)
- Male participants with partners of childbearing potential agree to use contraception and not donate sperm during trial
- Healthy participants or postmenopausal women with FSH levels ≥ 40 IU/L at screening (part B)
- Willing to attend all study visits and follow procedures
You will not qualify if you...
- History or presence of significant medical conditions
- History of any malignancy within 5 years except certain skin or cervical carcinomas fully treated
- Fasting serum triglycerides over 500 mg/dL at screening
- Estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2 for parts A, C, D or less than 60 mL/min/1.73 m2 for part B
- Abnormal ECG increasing risk or QT interval over 450 msec
- Abnormal blood pressure
- Positive HIV, hepatitis B or hepatitis C tests
- Known allergies or hypersensitivity to antibodies, study procedures, or severe food/drug allergies
- Major surgery within 30 days before study or planned during study
- Weight change over 5% in prior 3 months
- Regular weightlifting or strength training
- Use of GLP-1 receptor agonists or weight loss medication within 3 months before first dose
- Use of medications affecting FSH within 90 days before screening
- Use of any prescription, OTC, or herbal medicines within 14 days or 5 half-lives before dosing until last visit
- Received vaccine within 30 days before screening or plans to receive during study
- Participation in other clinical trials with investigational drugs/devices within 90 days or 5 half-lives before dosing
- Prior completion or withdrawal from this or similar studies
- Alcohol use exceeding limits or history of abuse
- Substance abuse or positive drug tests
- Smoking more than 5 cigarettes or tobacco products daily within 90 days prior or unwilling to stop during confinement
- Blood donation or blood loss over 400 mL within 30 days before screening
- Fasting or weight loss treatment within 30 days before dosing or major lifestyle changes
- Investigator or sponsor judgment of unsuitability
- Employment or close relation to study personnel
- Contraindications or inability to undergo MRI scanning for parts C and D only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia, 4006
Actively Recruiting
Research Team
J
Juan Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here