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RECRUITING
NCT07230496
PHASE1

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

Sponsor: Laekna Limited

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2025-12-30

Completion Date

2028-03-20

Last Updated

2026-01-20

Healthy Volunteers

Yes

Interventions

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

Locations (1)

Q-Pharm Pty Ltd.

Brisbane, Queensland, Australia