Clinical trial NCT06867718: Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions
Official title: A Phase 2 Study of Once-Daily RGT001-075 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities (COMO-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity or Overweight
Keywords: GLP-1 receptor agonist (GLP-1 RA)
Obesity
Lead sponsor: Regor Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent change from baseline in body weight at Week 36
timeFrame: Baseline and 36 weeks
Secondary outcomes:
measure: Percent change from baseline in body weight at Week 26
timeFrame: Baseline and 26 weeks
measure: Incidence of treatment emergent adverse events (TEAEs), TESAEs, TEAESIs overall
timeFrame: Baseline through week 36
measure: Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: Baseline, 26 weeks
measure: AUC0-last
timeFrame: week 15
measure: AUC0-inf
timeFrame: week 15
measure: Cmax
timeFrame: week15
measure: Tmax
timeFrame: week 15
measure: t1/2
timeFrame: week 15
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: Synexus Clinical Research
state: Arizona
city: Huntington Park
country: United States
facility: Velocity Clinical Research
state: California
city: Doral
country: United States
facility: Angels Clinical Research
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami
country: United States
facility: Angels Clinical Research
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research
state: Florida
city: Savannah
country: United States
facility: Javara-Privia Medical Group, Georgia LLC
state: Georgia
city: Thomasville
country: United States
facility: Javara-Privia Medical Group, Georgia, LLC
state: Georgia
city: Evansville
country: United States
facility: Synexus Clinical Research
state: Indiana
city: Valparaiso
country: United States
facility: Velocity Clinical Research
state: Indiana
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Rockville
country: United States
facility: Velocity Clinical Research
state: Maryland
city: Mankato
country: United States
facility: Mankato Clinic-East Main Street-Javara
state: Minnesota
city: Richfield
country: United States
facility: Synexus Clinical Research
state: Minnesota
city: Creve Coeur
country: United States
facility: Synexus Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Sparta
country: United States
facility: Premier Health Research-Sparta-Objective Health
state: New Jersey
city: Vestal
country: United States
facility: Velocity Clinical Research
state: New York
city: Charlotte
country: United States
facility: Javara-Tryon Medical Partners, PLLC
state: North Carolina
city: Durham
country: United States
facility: Velocity Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: East Greenwich
country: United States
facility: Velocity Clinical Research
state: Rhode Island
city: Dallas
country: United States
facility: Velocity Clinical Research
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Synexus Clinical Research
state: Texas
city: The Woodlands
country: United States
facility: Javara-Privia Medical Group Gulf Coast PLLC
state: Texas
city: Waco
country: United States
facility: Velocity Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Synexus Clinical Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research
state: Utah
city: Seattle
country: United States
facility: Velocity Clinical Research
state: Washington
Study officials:
References: