NCT06606483

A Study to Evaluate the Efficacy and Safety of MDR-001 in Subjects Who Are Obesity or Overweight

A 24 Weeks, Multicenter, Randomized, Double-blind, Placebo, Parallel-controlled Phase IIb Trail Comparing the Efficacy and Safety of MDR-001 Tablet Versus Placebo in Subjects With Overweight or Obesity

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: MindRank AI Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a 24 weeks, multicenter, randomized, double-blind, placebo, parallel-controlled Phase IIb trail comparing the efficacy and safety of MDR-001 tablet versus placebo as an adjunct to a reduced calorie diet and increased physical activity in subjects with overweight or obesity, and to explore the optimal dose selection to support the subsequent Pivotal trial.

Conditions

• Obesity
• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	MDR-001	Oral administration of small molecule MDR-001 tablets
DRUG	Placebo	Administered orally placebo

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-07-30
• Completion: 2025-09-30
• First posted: 2024-09-23
• Last updated: 2024-09-24

Locations

19 sites across 1 country: China