NCT06867718

Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions

A Phase 2 Study of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Regor Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.

Conditions

• Obesity or Overweight

Interventions

Type	Name	Description
DRUG	RGT001-075	RGT001-075 is a small molecule GLP-1 agonist
DRUG	Placebo Comparator	Placebo comparator

Timeline

• Start date: 2025-01-24
• Primary completion: 2025-09-19
• Completion: 2025-12-12
• First posted: 2025-03-10
• Last updated: 2025-04-02

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study