A Study of RGT001-075 in Adult Patients With Obesity

Obesity Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of RGT001-075 Compared With Placebo in Adult Patients With Obesity or Overweight

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277934
• Other study ID #: RGT001-075-203
• Status: Recruiting
• Phase: Phase 2
• Start date: March 8, 2024
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Regor Pharmaceuticals Inc.
• Contact: Dawn Begley
• Phone: 8572938352
• Email: dawn.begley[@]regor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• RGT001-075
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Cleveland	Ohio
United States	Velocity Clinical Research	Dallas	Texas
United States	Velocity Clinical Research	Durham	North Carolina
United States	Velocity Clinical Research	East Greenwich	Rhode Island
United States	Velocity Clinical Research	Los Angeles	California
United States	Velocity Clinical Research	Medford	Oregon
United States	Velocity Clinical Research	Omaha	Nebraska
United States	Velocity Clinical Research	Valparaiso	Indiana
United States	Velocity Clinical Research	Vestal	New York
United States	Velocity Clinical Research	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Regor Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent change in body weight	Percent change in body weight from baseline at Week 12	12 weeks
Secondary	Change in body weight in kilogram	Change in body weight from baseline at Week 12	12 weeks
Secondary	Percentage of participants who achieve =5% and =10% body weight reduction	Percentage of participants who achieve =5% and =10% body weight reduction at Week 12	12 weeks
Secondary	Change in Body mass index (BMI) in kg/m^2	Change in BMI from baseline at Week 12	12 weeks
Secondary	Change in waist circumference in centimetre	Change in waist circumference from baseline at Week 12 .	12 weeks
Secondary	RGT001-075 pharmacokinetics (PK): Area under the curve up to the last measured concentration(AUC0-last)	Analysis of AUC0-last	12 weeks
Secondary	RGT001-075 pharmacokinetics (PK): Area under curve from time zero to time infinite(AUC0-inf)	Analysis of AUC0-inf	12 weeks
Secondary	RGT001-075 pharmacokinetics (PK): Maximum observed concentration (Cmax)	Analysis of Cmax	12 weeks
Secondary	RGT001-075 pharmacokinetics (PK): Time to achieve maximum concentration(Tmax)	Analysis of Tmax	12 weeks
Secondary	RGT001-075 pharmacokinetics (PK): Elimination half-life(t1/2)	Analysis of t1/2	12 weeks