Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions (COMO-1)

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)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Alliance for Multispecialty Research, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Synexus Clinical Research
  • California
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research
  • Florida
    • Doral, Florida, United States, 33122
      • Angels Clinical Research
    • Melbourne, Florida, United States, 32934
      • Optimal Research
    • Miami, Florida, United States, 33126
      • Angels Clinical Research
    • Miami Lakes, Florida, United States, 33014
      • Palm Springs Community Health Center
    • The Villages, Florida, United States, 32162
      • Synexus Clinical Research
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Javara-Privia Medical Group, Georgia LLC
    • Thomasville, Georgia, United States, 31792
      • Javara-Privia Medical Group, Georgia, LLC
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Synexus Clinical Research
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispecialty Research, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Velocity Clinical Research
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Velocity Clinical Research
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Mankato Clinic-East Main Street-Javara
    • Richfield, Minnesota, United States, 55423
      • Synexus Clinical Research
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Synexus Clinical Research
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research
  • New Jersey
    • Sparta, New Jersey, United States, 07871
      • Premier Health Research-Sparta-Objective Health
  • New York
    • Vestal, New York, United States, 13850
      • Velocity Clinical Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28287
      • Javara-Tryon Medical Partners, PLLC
    • Durham, North Carolina, United States, 27701
      • Velocity Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Velocity Clinical Research
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Alliance for Multispecialty Research, LLC
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research
  • Texas
    • Dallas, Texas, United States, 75234
      • Synexus Clinical Research
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Research
    • San Antonio, Texas, United States, 78229
      • Synexus Clinical Research
    • The Woodlands, Texas, United States, 77384
      • Javara-Privia Medical Group Gulf Coast PLLC
    • Waco, Texas, United States, 76710
      • Velocity Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Synexus Clinical Research
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research
  • Washington
    • Seattle, Washington, United States, 98105
      • Velocity Clinical Research

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
2. Hemoglobin A1c (HbA1c) <6.5% at screening.
3. BMI ≥30 kg/m².

4. BMI ≥27 kg/m² and <30 kg/m² with at least 1 weight-related comorbidity:

   • hypertension
   • dyslipidemia
   • cardiovascular (CV) disease
   • obstructive sleep apnea
5. Have a stable body weight (< 5% change) for the 3 months prior to randomization.

Exclusion Criteria (Obesity Related):

1. Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
2. Have a prior or planned surgical treatment for obesity.
3. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner.
4. Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening.

Exclusion Criteria (Medical Conditions)

1. Diabetes.
2. Have a history of acute or chronic pancreatitis.
3. Have current symptomatic gallbladder disease or biliary disease.
4. Have known liver disease other than MASLD.
5. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).
6. Have a serum calcitonin ≥20 pg/mL.
7. Have an eGFR <30 mL/min/1.73 m², as determined by the central laboratory at screening.
8. Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
9. Have had any exposure to GLP-1 analogs, or other related compounds within the prior 3 months or any prior history of clinically significant side effects from GLP-1 receptor agonist (GLP-1 RA) or other related compounds containing GLP-1.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Comparator; Placebo comparator
Experimental: RGT1; Study Drug: RGT001-075 (Dose 1)	Drug: RGT001-075; RGT001-075 is a small molecule GLP-1 agonist
Experimental: RGT2; Study Drug: RGT001-075 (Dose 2)	Drug: RGT001-075; RGT001-075 is a small molecule GLP-1 agonist
Experimental: RGT3; Study Drug: RGT001-075 (Dose 3)	Drug: RGT001-075; RGT001-075 is a small molecule GLP-1 agonist
Experimental: RGT4; Study Drug: RGT001-075 (Dose 4)	Drug: RGT001-075; RGT001-075 is a small molecule GLP-1 agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in body weight at Week 36	Least Squares (LS) mean using mixed model repeated measures (MMRM)	Baseline and 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from baseline in body weight at Week 26	Least Squares (LS) mean using mixed model repeated measures (MMRM)	Baseline and 26 weeks
Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall	To evaluate the safety and tolerability of RGT001-075 for weight loss in adults who are obese, or overweight with at least one weight-related comorbidity	Baseline through week 36
Ambulatory Blood Pressure Monitoring (ABPM)	The ABPM device will be attached to the nondominant arm, and participants will be instructed to wear the monitor for a 24- to 27-hour period.	Baseline, 26 weeks
AUC0-last	Area under the serum concentration curve from time-zero to the last quantifiable concentration of RGT001-075	week 15
AUC0-inf	Area under curve from time zero to time infinite	week 15
Cmax	Maximum concentration of RT001-075	week15
Tmax	Time to achieve maximum concentration of RT001-075	week 15
t1/2	Terminal half-life of RGT001-075	week 15

Collaborators and Investigators

• Sponsor: Regor Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; GLP-1 receptor agonist (GLP-1 RA)
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: RGT001-075-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Sponsor recognizes that sharing anonymized data and other information from clinical trials can enhance biomedical research. The Sponsor is following ongoing discussions among industry, academia, and other stakeholders regarding data sharing. Industry and academic partners hold various positions on the amount, types, and forms of data that will be useful l to the research community, the public, and the process for sharing. As a small, young company, the Sponsor awaits further guidance and input from industry participants on best practices before issuing a comprehensive data sharing plan. For now, Sponsor defers a description of what data will be shared and the process for doing so.

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