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drugset / Trial / NCT06606483

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

NCT06606483 ↗

Phase 2 Not yet recruiting 300 enrolled MindRank AI Ltd
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2024-09-23
Primary completion
2025-07-30
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MDR-001 Small molecule 90 mg Oral
Subject MDR-001 Small molecule 120 mg Oral
Subject MDR-001 Small molecule 150 mg Oral
Subject MDR-001 Small molecule 180 mg Oral

Indications

obesity disorder