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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity or Overweight

In brief

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.

Key facts

Study ID

NCT06867718

Run by

Regor Pharmaceuticals Inc.

People needed

267

Starts

2025-01-24

Expected to finish

2025-11-06

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 18-75 years (inclusive) at the time of signing informed consent.
• Hemoglobin A1c (HbA1c) <6.5% at screening.
• BMI ≥30 kg/m².
• BMI ≥27 kg/m² and <30 kg/m² with at least 1 weight-related comorbidity:
• hypertension
• dyslipidemia
• cardiovascular (CV) disease
• obstructive sleep apnea
• Have a stable body weight (< 5% change) for the 3 months prior to randomization.
• Exclusion Criteria (Obesity Related):
• 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).
• Have a prior or planned surgical treatment for obesity.
• 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.
• 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)
• Diabetes.
• Have a history of acute or chronic pancreatitis.
• Have current symptomatic gallbladder disease or biliary disease.
• Have known liver disease other than MASLD.
• 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).
• Have a serum calcitonin ≥20 pg/mL.
• Have an eGFR <30 mL/min/1.73 m², as determined by the central laboratory at screening.
• Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.