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ACTIVE NOT RECRUITING

NCT06867718

PHASE2

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

Sponsor: Regor Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2025-01-24

Completion Date

2025-12-12

Last Updated

2025-04-02

Healthy Volunteers

Conditions

Obesity or Overweight

Interventions

DRUG

RGT001-075

RGT001-075 is a small molecule GLP-1 agonist

DRUG

Placebo Comparator

Placebo comparator

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.

Locations (35)

Alliance for Multispecialty Research, LLC

Mobile, Alabama, United States

Synexus Clinical Research

Phoenix, Arizona, United States

Velocity Clinical Research

Huntington Park, California, United States

Angels Clinical Research

Doral, Florida, United States

Optimal Research

Melbourne, Florida, United States

Angels Clinical Research

Miami, Florida, United States

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Synexus Clinical Research

The Villages, Florida, United States

Javara-Privia Medical Group, Georgia LLC

Savannah, Georgia, United States

Javara-Privia Medical Group, Georgia, LLC

Thomasville, Georgia, United States

Synexus Clinical Research

Evansville, Indiana, United States

Velocity Clinical Research

Valparaiso, Indiana, United States

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, United States

Velocity Clinical Research

Baton Rouge, Louisiana, United States

Velocity Clinical Research

Rockville, Maryland, United States

Mankato Clinic-East Main Street-Javara

Mankato, Minnesota, United States

Synexus Clinical Research

Richfield, Minnesota, United States

Synexus Clinical Research

Creve Coeur, Missouri, United States

Velocity Clinical Research

Omaha, Nebraska, United States

Premier Health Research-Sparta-Objective Health

Sparta, New Jersey, United States

Velocity Clinical Research

Vestal, New York, United States

Javara-Tryon Medical Partners, PLLC

Charlotte, North Carolina, United States

Velocity Clinical Research

Durham, North Carolina, United States

Velocity Clinical Research

Cincinnati, Ohio, United States

Velocity Clinical Research

Cleveland, Ohio, United States

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Velocity Clinical Research

East Greenwich, Rhode Island, United States

Velocity Clinical Research

Dallas, Texas, United States

Synexus Clinical Research

Dallas, Texas, United States

Synexus Clinical Research

San Antonio, Texas, United States

Javara-Privia Medical Group Gulf Coast PLLC

The Woodlands, Texas, United States

Velocity Clinical Research

Waco, Texas, United States

Synexus Clinical Research

Salt Lake City, Utah, United States

Velocity Clinical Research

West Jordan, Utah, United States

Velocity Clinical Research

Seattle, Washington, United States

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (35)