A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight With Weight-Related Comorbidities

The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: RGT001-075

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research
  • New York
    • Vestal, New York, United States, 13850
      • Velocity Clinical Research
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Velocity Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research
  • Texas
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Research
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 and ≤ 75 years
• Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
• Have had a stable body weight for the 3 months prior to randomization

Exclusion Criteria:

• Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
• Have a prior or planned surgical treatment for obesity
• Have or plan to have endoscopic and/or device-based therapy for obesity
• Have any prior diagnosis of diabetes
• Have an electrocardiogram (ECG) with abnormalities
• Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years
• Have a history of suicide attempt.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RGT001-075 Group; Patients will receive once daily dose of study drug for a total of 12 weeks	Drug: RGT001-075; Administered orally; Other Names: Active drug
Placebo Comparator: Placebo Group; Patients will receive once daily dose of matching placebo for a total of 12 weeks	Drug: Placebo; Administered orally; Other Names: Placebo drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in body weight	Percent change in body weight from baseline at Week 12	12 weeks
Change in body weight in kilogram	Change in body weight from baseline at Week 12	12 weeks
Percentage of participants who achieve ≥5% and ≥10% body weight reduction	Percentage of participants who achieve ≥5% and ≥10% body weight reduction at Week 12	12 weeks
Change in Body mass index (BMI) in kg/m^2	Change in BMI from baseline at Week 12	12 weeks
Change in waist circumference in centimetre	Change in waist circumference from baseline at Week 12 .	12 weeks
RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)	Analysis of AUC0-last	12 weeks
RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)	Analysis of AUC0-inf	12 weeks
RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)	Analysis of Cmax	12 weeks
RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)	Analysis of Tmax	12 weeks
RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)	Analysis of t1/2	12 weeks

Collaborators and Investigators

• Sponsor: Regor Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Actual): August 13, 2024
• Study Completion (Actual): August 13, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 18, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: RGT001-075-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No