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

NCT06867718 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: RGT001-075-205
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 35

Brief 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.

Conditions

Obesity or Overweight

Keywords

GLP-1 receptor agonist (GLP-1 RA); Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percent change from baseline in body weight at Week 26

  Baseline and 26 weeks

• Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall

  Baseline through week 36

• Ambulatory Blood Pressure Monitoring (ABPM)

  Baseline, 26 weeks

• AUC0-last

  week 15

• AUC0-inf

  week 15

Study Arms (5)

RGT1

EXPERIMENTAL

Study Drug: RGT001-075 (Dose 1)

Drug: RGT001-075

RGT2

EXPERIMENTAL

Study Drug: RGT001-075 (Dose 2)

Drug: RGT001-075

RGT3

EXPERIMENTAL

Study Drug: RGT001-075 (Dose 3)

Drug: RGT001-075

RGT4

EXPERIMENTAL

Study Drug: RGT001-075 (Dose 4)

Drug: RGT001-075

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Comparator

Interventions

RGT001-075 DRUG

RGT001-075 is a small molecule GLP-1 agonist

RGT1; RGT2; RGT3; RGT4

Placebo Comparator DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Regor Pharmaceuticals Inc.: lead

Study Sites (35)

Alliance for Multispecialty Research, LLC

Mobile, Alabama, 36608, United States

Location

Synexus Clinical Research

Phoenix, Arizona, 85020, United States

Location

Velocity Clinical Research

Huntington Park, California, 90255, United States

Location

Angels Clinical Research

Doral, Florida, 33122, United States

Location

Optimal Research

Melbourne, Florida, 32934, United States

Location

Angels Clinical Research

Miami, Florida, 33126, United States

Location

Palm Springs Community Health Center

Miami Lakes, Florida, 33014, United States

Location

Synexus Clinical Research

The Villages, Florida, 32162, United States

Location

Javara-Privia Medical Group, Georgia LLC

Savannah, Georgia, 31406, United States

Location

Javara-Privia Medical Group, Georgia, LLC

Thomasville, Georgia, 31792, United States

Location

Synexus Clinical Research

Evansville, Indiana, 47714, United States

Location

Velocity Clinical Research

Valparaiso, Indiana, 46383, United States

Location

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Velocity Clinical Research

Baton Rouge, Louisiana, 70809, United States

Location

Velocity Clinical Research

Rockville, Maryland, 20854, United States

Location

Mankato Clinic-East Main Street-Javara

Mankato, Minnesota, 56001, United States

Location

Synexus Clinical Research

Richfield, Minnesota, 55423, United States

Location

Synexus Clinical Research

Creve Coeur, Missouri, 63141, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

Premier Health Research-Sparta-Objective Health

Sparta, New Jersey, 07871, United States

Location

Velocity Clinical Research

Vestal, New York, 13850, United States

Location

Javara-Tryon Medical Partners, PLLC

Charlotte, North Carolina, 28287, United States

Location

Velocity Clinical Research

Durham, North Carolina, 27701, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45246, United States

Location

Velocity Clinical Research

Cleveland, Ohio, 44122, United States

Location

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, 73069, United States

Location

Velocity Clinical Research

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research

Dallas, Texas, 75230, United States

Location

Synexus Clinical Research

Dallas, Texas, 75234, United States

Location

Synexus Clinical Research

San Antonio, Texas, 78229, United States

Location

Javara-Privia Medical Group Gulf Coast PLLC

The Woodlands, Texas, 77384, United States

Location

Velocity Clinical Research

Waco, Texas, 76710, United States

Location

Synexus Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Velocity Clinical Research

West Jordan, Utah, 84088, United States

Location

Velocity Clinical Research

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 10, 2025
• Study Start: January 24, 2025
• Primary Completion: September 19, 2025
• Study Completion: December 12, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

US (35)