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

ACTIVE_NOT_RECRUITINGPHASE2

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)

NCT06867718•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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

•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.
•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.
+3 more criteria

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

Key Dates

Start Date

January 24, 2025

Primary Completion Date

September 19, 2025

Completion Date

December 12, 2025

Last Updated

April 2, 2025

Enrollment

236

ESTIMATED participants

Conditions

Obesity or Overweight

Interventions

RGT001-075

DRUG

Placebo Comparator

DRUG

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NCT07255209

Adolescents With Obesity or Overweight With Weight-Related Comorbidities

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RECRUITINGPHASE1

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NCT07128888

Obesity or Overweight

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ACTIVE_NOT_RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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