Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions (COMO-1)

Regor Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Obesity or Overweight

Treatments: Drug: Placebo Comparator; Drug: RGT001-075

Study type: Interventional

Funder types: Industry

Identifiers

NCT06867718

RGT001-075-205

Details and patient eligibility

About

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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 5 patient groups, including a placebo group

RGT1

Experimental group

Description:

Study Drug: RGT001-075 (Dose 1)

Treatment:

Drug: RGT001-075

RGT2

Experimental group

Description:

Study Drug: RGT001-075 (Dose 2)

Treatment:

Drug: RGT001-075

RGT3

Experimental group

Description:

Study Drug: RGT001-075 (Dose 3)

Treatment:

Drug: RGT001-075

RGT4

Experimental group

Description:

Study Drug: RGT001-075 (Dose 4)

Treatment:

Drug: RGT001-075

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo Comparator