RGT001-075 for Obesity
(COMO-1 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Regor Pharmaceuticals Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults who are obese with a BMI of 30 or higher, or overweight with a BMI of at least 27 and have one weight-related health issue. Specific eligibility details aren't provided, but typically participants must meet certain health standards to join.

Inclusion Criteria

Hemoglobin A1c (HbA1c) <6.5% at screening.

BMI ≥30 kg/m2.

Have a stable body weight (< 5% change) for the 3 months prior to randomization.

+2 more

Exclusion Criteria

Have a serum calcitonin ≥20 pg/mL.

I have used weight loss drugs or remedies in the past 3 months.

I have diabetes.

+10 more

Participant Groups

The study is testing RGT001-075, an oral medication taken once daily against a placebo (a pill without the active drug) to see if it's safe and effective in helping people lose weight over a period of 36 weeks.

5Treatment groups

Experimental Treatment

Placebo Group

Group I: RGT4Experimental Treatment1 Intervention

Study Drug: RGT001-075 (Dose 4)

Group II: RGT3Experimental Treatment1 Intervention

Study Drug: RGT001-075 (Dose 3)

Group III: RGT2Experimental Treatment1 Intervention

Study Drug: RGT001-075 (Dose 2)

Group IV: RGT1Experimental Treatment1 Intervention

Study Drug: RGT001-075 (Dose 1)

Group V: PlaceboPlacebo Group1 Intervention