NCT07230496

A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants

A Phase I, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LAE103 as Single and Multiple Ascending Doses in Healthy Overweight/Obese Participants, and as Single Dose in Healthy Postmenopausal Women, With an Additional Evaluation of Single Ascending Dose of LAE103 in Combination With LAE102 in Healthy Overweight/Obese Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Laekna Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a randomized, double-blind study comprising of a single-dose escalation study in healthy overweight/obese participants (Part A), a single dose study in healthy postmenopausal women (Part B), and a multiple-dose escalation study in healthy overweight/obese participants (Part C), designed to evaluate the safety, tolerability, Pharmacokinetics (PK )and pharmacodynamics (PD) profiles of LAE103 administered alone. In addition, the study will also investigate the safety, tolerability, and PK/PD profiles of a single-dose co-administration of LAE102 and LAE103 in healthy overweight/obese participants (Part D). About 104 participants will be enrolled in 13 cohorts with each cohort including 8 participants randomized 6:2 study drug:Placebo.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	LAE103 injection	subcutaneous injection of LAE103 alone
DRUG	LAE102 injection in combined with LAE103 injection	LAE102 injection in combined with LAE103 injection via subcutaneous
DRUG	Saline	Saline via subcutaneous

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-03-20
• Completion: 2028-03-20
• First posted: 2025-11-17
• Last updated: 2026-01-20

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study