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

Phase 2

Active, not recruiting

• Conditions: Obesity or Overweight
• Interventions: Drug: RGT001-075; Drug: Placebo Comparator

• Registration Number: NCT06867718
• Lead Sponsor: Regor Pharmaceuticals Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-24
• Study First Submitted: 2025-02-14
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-09-19
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 236

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 (Obesity Related):

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.

Exclusion Criteria (Medical Conditions)

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.
7. Have an eGFR <30 mL/min/1.73 m², as determined by the central laboratory at screening.
8. Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years.
9. 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RGT1	RGT001-075	Study Drug: RGT001-075 (Dose 1)
RGT2	RGT001-075	Study Drug: RGT001-075 (Dose 2)
RGT3	RGT001-075	Study Drug: RGT001-075 (Dose 3)
RGT4	RGT001-075	Study Drug: RGT001-075 (Dose 4)
Placebo	Placebo Comparator	Placebo

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in body weight at Week 36	Baseline and 36 weeks	Least Squares (LS) mean using mixed model repeated measures (MMRM)

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline in body weight at Week 26	Baseline and 26 weeks	Least Squares (LS) mean using mixed model repeated measures (MMRM)
Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall	Baseline through week 36	To evaluate the safety and tolerability of RGT001-075 for weight loss in adults who are obese, or overweight with at least one weight-related comorbidity
Ambulatory Blood Pressure Monitoring (ABPM)	Baseline, 26 weeks	The ABPM device will be attached to the nondominant arm, and participants will be instructed to wear the monitor for a 24- to 27-hour period.
AUC0-last	week 15	Area under the serum concentration curve from time-zero to the last quantifiable concentration of RGT001-075
AUC0-inf	week 15	Area under curve from time zero to time infinite
Cmax	week15	Maximum concentration of RT001-075
Tmax	week 15	Time to achieve maximum concentration of RT001-075
t1/2	week 15	Terminal half-life of RGT001-075

Trial Locations

Locations (12)

Velocity Clinical Research; 🇺🇸 Seattle, Washington, United States

Javara-Privia Medical Group Gulf Coast PLLC; 🇺🇸 The Woodlands, Texas, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norman, Oklahoma, United States

Synexus Clinical Research; 🇺🇸 Salt Lake City, Utah, United States

Angels Clinical Research; 🇺🇸 Miami, Florida, United States

Optimal Research; 🇺🇸 Melbourne, Florida, United States

Palm Springs Community Health Center; 🇺🇸 Miami Lakes, Florida, United States

Javara-Privia Medical Group, Georgia LLC; 🇺🇸 Savannah, Georgia, United States

Javara-Privia Medical Group, Georgia, LLC; 🇺🇸 Thomasville, Georgia, United States

Mankato Clinic-East Main Street-Javara; 🇺🇸 Mankato, Minnesota, United States

Premier Health Research-Sparta-Objective Health; 🇺🇸 Sparta, New Jersey, United States

Javara-Tryon Medical Partners, PLLC; 🇺🇸 Charlotte, North Carolina, United States