NCT06500299

Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults.

Detailed description

This multicenter, randomized, double-blind, placebo-controlled phase II clinical trial aims to evaluate the safety and efficacy of HDM1002 tablets in overweight and obese adults. Participants with a BMI between 24 and 40 will be include. A total of 180 participants will be randomized in a 1:1:1:1 ratio to receive different doses of HDM1002 or placebo. Following the screening period to confirm eligibility up to 2-weeks, the study will consist of a treatment period will be 12 weeks, followed by an approximate 4-week follow-up.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	HDM1002 100 mg QD	HDM1002 tablets 100mg daily, 12weeks
DRUG	HDM1002 200 mg QD 12weeks	HDM1002 tablets 200mg daily, 12weeks
DRUG	HDM1002 400 mg QD 12weeks	HDM1002 tablets 400mg daily, 12weeks
DRUG	Placebo	Matching placebo will be provided

Timeline

• Start date: 2024-07-15
• Primary completion: 2024-10-30
• Completion: 2024-11-30
• First posted: 2024-07-15
• Last updated: 2024-07-15

Regulatory

• FDA-regulated drug study