Actively Recruiting
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LAE103 Alone or with LAE102 in Healthy Overweight/Obese Adults and Postmenopausal Women
Led by Laekna Limited · Updated on 2026-01-20
104
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes the drug LAE103 in healthy overweight or obese adults and healthy postmenopausal women. This Phase 1, randomized, double-blind study also explores the safety and early effects of multiple doses of LAE103 and examines the safety and pharmacokinetics of LAE103 when combined with another drug, LAE102, in overweight or obese participants. The study aims to gather important information about these treatments in these specific groups to support further research. The study includes several parts: a single-dose escalation in overweight/obese participants, a single-dose in postmenopausal women, a multiple-dose escalation in overweight/obese participants, and a single-dose co-administration of LAE102 with LAE103 in overweight/obese participants. About 104 participants will be enrolled across 13 groups, each with 8 people randomized to receive either the study drug or placebo. Treatments are given as subcutaneous injections, with some participants receiving LAE103 alone, some saline as placebo, and others the combination of LAE102 and LAE103. Participants will attend study visits for monitoring during the treatment and follow-up periods, which last up to 70 days for single-dose parts and up to 98 days for multiple-dose parts. Researchers will assess safety by tracking any treatment-related side effects and monitor how the drug moves through and affects the body using blood tests for drug levels and biological markers. They will also test for immune responses to the drug and evaluate hormone levels. This thorough monitoring helps ensure participant safety and gathers comprehensive data about the treatments.
CONDITIONS
Brief 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 procedures
- 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) between 25.0 and 40.0 kg/m2 in Parts A, C, D; BMI between 20.0 and 35.0 kg/m2 in Part B
- Not pregnant or breastfeeding and agree to use two effective contraception methods if able to have children
- Male participants with female partners of childbearing potential must use contraception and not donate sperm during the trial
- Healthy participants or with follicle-stimulating hormone (FSH) levels ≥ 40 IU/L at screening (Part B only)
- Willing to attend all study visits and follow study protocol
You will not qualify if you...
- History or presence of significant medical conditions
- History of cancer within the past 5 years except certain skin and cervical cancers treated with no spread for 3 years
- Fasting serum triglycerides over 500 mg/dL at screening
- Low kidney function (eGFR below 90 mL/min/1.73 m2 for Parts A, C, D; below 60 mL/min/1.73 m2 for Part B)
- Abnormal ECG or prolonged QT interval over 450 msec
- Abnormal blood pressure
- Positive tests for HIV, hepatitis B, or hepatitis C
- Known allergies to antibodies, study procedures, or severe food or drug allergies
- Major surgery within 30 days before dosing or planned during the study
- Weight change over 5% in last 3 months
- Regular strength training aimed at increasing muscle strength
- Use of GLP-1 receptor agonists or weight loss medications within 3 months before dosing
- Use of medications affecting FSH levels within 90 days before dosing
- Use of prescription, over-the-counter, or herbal medicines within 14 days or 5 half-lives before dosing
- Vaccination within 30 days before dosing or planned during the study
- Participation in another clinical trial involving investigational drugs or devices within 90 days
- Previously completed or withdrawn from this or similar studies
- Excessive alcohol use or positive alcohol test at screening
- History or current substance abuse or positive drug test
- Smoking more than 5 cigarettes per day within 90 days before screening
- Blood donation or loss over 400 mL within 30 days before screening
- Fasting or weight loss treatment within 30 days before dosing or major lifestyle changes
- Considered unsuitable by investigator or sponsor
- Employees or immediate family of study staff or sponsor
- Contraindications for MRI or not meeting MRI requirements (Parts C and D only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 weeks depending on dosing regimen
Participants receive single or multiple subcutaneous injections of LAE103 alone, LAE102 combined with LAE103, or placebo to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits during dosing and monitoring period
Duration - Up to 12 weeks after last dose
Participants are monitored for safety, tolerability, and pharmacodynamics after treatment ends.
Regular visits for safety and blood sample collection
Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Brisbane, Queensland, Australia, 4006
Actively Recruiting
Research Team
J
Juan Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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