A Study Evaluating the Safety and Efficacy of Oral LMN-0801 Capsules for Weight Loss.

A Dose-ranging Study Evaluating the Safety and Efficacy of LMN-0801 for Weight Loss in Overweight Adults

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000559415

Enrollment

Registered

2025-06-02

Start date

2025-08-20

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a dose-ranging study to evaluate the safety and preliminary efficacy of LMN-0801 for weight loss. 126 adults with obesity (BMI > 30 and BMI < 40) will participate in the study. LMN-0801 will be assessed across dose levels, frequency of dosing, and different formulations of LMN-0801. After enrollment and randomization into one of ten cohorts, participants will take the study drug for 24 weeks and then be followed for an additional 4 weeks. During this time participants will come into the clinic for scheduled study visits to monitor safety, undergo study evaluations and measurements, assess study drug adherence and replenish study drug supplies. Each participant will be in the study for a duration of 29 weeks from enrollment.

Interventions

Three oral capsules (400 mg per capsule) containing LMN-0801 taken once per day (Group 1 and 2), twice per day (Group 4-6) and three times per day (Group 7-10) for 24 weeks. Participants will be completing a daily questionnaire to record drug self-administration. Participants will also bring used and unused drug packaging with them to each clinic visit for drug accountability.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

• Adults aged 18 years and over and under age 65 years • Body Mass Index (BMI) > 30 and < 40 • HbA1c < 6.5% • In good general health • Females agree to eliminate risk of pregnancy

Exclusion criteria

• Significant illness, abnormal physical exam, lab findings (investigator discretion) • Alcohol abuse or drug dependency or tobacco use • Pregnant, breastfeeding, or planning to become pregnant or breastfeed • Use of weight loss drugs and/or antidiabetic agents in preceding six months • Currently treated with excluded medications • Have previously completed or withdrawn from this study • Participation in another clinical trial now or in the prior three months

Outcome results