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

NCT07230496 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

  • Overweight and Obesity

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

Sponsors & Collaborators

  • Laekna Limited

    lead INDUSTRY

Principal Investigators

  • Michael Wong · Q-Pharm Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2028-03-20
Completion
2028-03-20
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07230496 on ClinicalTrials.gov