A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities

NCT06277934 | Completed Phase 2 FDA Drug

• 1 other identifier: RGT001-075-203
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 10

Brief Summary

The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings

  14 weeks

Secondary Outcomes (10)

• Percent change in body weight

  12 weeks

• Change in body weight in kilogram

  12 weeks

• Percentage of participants who achieve ≥5% and ≥10% body weight reduction

  12 weeks

• Change in Body mass index (BMI) in kg/m^2

  12 weeks

• Change in waist circumference in centimetre

  12 weeks

Study Arms (2)

RGT001-075 Group

EXPERIMENTAL

Patients will receive once daily dose of study drug for a total of 12 weeks

Drug: RGT001-075

Placebo Group

PLACEBO COMPARATOR

Patients will receive once daily dose of matching placebo for a total of 12 weeks

Drug: Placebo

Interventions

RGT001-075 DRUG

Administered orally

RGT001-075 Group

Placebo DRUG

Administered orally

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 and ≤ 75 years
• Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
• Have had a stable body weight for the 3 months prior to randomization

You may not qualify if:

• Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
• Have a prior or planned surgical treatment for obesity
• Have or plan to have endoscopic and/or device-based therapy for obesity
• Have any prior diagnosis of diabetes
• Have an electrocardiogram (ECG) with abnormalities
• Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years
• Have a history of suicide attempt.

Sponsors & Collaborators

• Regor Pharmaceuticals Inc.: lead

Study Sites (10)

Velocity Clinical Research

Los Angeles, California, 90057, United States

Location

Velocity Clinical Research

Valparaiso, Indiana, 46383, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

Velocity Clinical Research

Vestal, New York, 13850, United States

Location

Velocity Clinical Research

Durham, North Carolina, 27701, United States

Location

Velocity Clinical Research

Cleveland, Ohio, 44122, United States

Location

Velocity Clinical Research

Medford, Oregon, 97504, United States

Location

Velocity Clinical Research

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research

Dallas, Texas, 75230, United States

Location

Velocity Clinical Research

West Jordan, Utah, 84088, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 26, 2024
• Study Start: March 8, 2024
• Primary Completion: August 13, 2024
• Study Completion: August 13, 2024
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)