RGT001-075 for Obesity

(COMO-1 Trial)

Recruiting at 34 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regor Pharmaceuticals Inc.

Must not be taking: GLP-1 analogs

Disqualifiers: Diabetes, Pancreatitis, Gallbladder disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

236 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot have used weight loss drugs or GLP-1 analogs in the last 3 months before joining.

How does the treatment RGT001-075 for obesity differ from other treatments?

The treatment RGT001-075 may involve a novel approach similar to reverse gastric pacing (RGP), which reduces food intake without causing symptoms, unlike traditional methods that often rely on dietary restrictions or surgery. ^{1 2 3 4 5}

What data supports the effectiveness of the drug RGT001-075 for obesity?

The research on Retatrutide, a similar drug that targets incretin receptors, shows promise in managing obesity, suggesting that RGT001-075 might also be effective if it works in a similar way. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults who are obese with a BMI of 30 or higher, or overweight with a BMI of at least 27 and have one weight-related health issue. Specific eligibility details aren't provided, but typically participants must meet certain health standards to join.

Inclusion Criteria

Hemoglobin A1c (HbA1c) <6.5% at screening.

BMI ≥30 kg/m2.

Have a stable body weight (< 5% change) for the 3 months prior to randomization.

Exclusion Criteria

Have a serum calcitonin ≥20 pg/mL.

I have used weight loss drugs or remedies in the past 3 months.

I have diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RGT001-075 or placebo once daily to evaluate safety, tolerability, and weight loss efficacy

36 weeks

Regular visits throughout the treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RGT001-075

Trial Overview The study is testing RGT001-075, an oral medication taken once daily against a placebo (a pill without the active drug) to see if it's safe and effective in helping people lose weight over a period of 36 weeks.

How Is the Trial Designed?

Group I: RGT4 Experimental Treatment 1 Intervention

Study Drug: RGT001-075 (Dose 4)

Group II: RGT3 Experimental Treatment 1 Intervention

Study Drug: RGT001-075 (Dose 3)

Group III: RGT2 Experimental Treatment 1 Intervention

Study Drug: RGT001-075 (Dose 2)

Group IV: RGT1 Experimental Treatment 1 Intervention

Study Drug: RGT001-075 (Dose 1)

Group V: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Regor Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

440+

Published Research Related to This Trial

An 8-week multidisciplinary residential program (MRP) for obesity led to significant weight loss and improvements in body composition and metabolic parameters in 168 participants, including a reduction in total mass by 5.68 kg and fat mass by 4416.85 g.

The program's benefits, including continued BMI reduction over a year, highlight the effectiveness of combining a hypocaloric diet, physical exercise, and psychological support in treating obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary residential program for the treatment of obesity: how body composition assessed by DXA and blood chemistry parameters change during hospitalization and which variations in body composition occur from discharge up to 1-year follow-up. Gasparri, C., Perna, S., Peroni, G., et al.[2023]

In a study of 131 young obese patients who underwent bariatric surgery, significant improvements in body weight, blood pressure, fasting plasma glucose, HbA1c, and triglyceride levels were observed within one to three months post-surgery.

Age and pre-operative HbA1c levels were identified as key predictors for HbA1c reduction, while pre-operative body weight was a strong predictor for weight loss, highlighting the importance of these factors in post-surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rapid Changes in Bodyweight and Glycemic Control Are Determined by Pre-status After Bariatric Surgery in Both Genders in Young Chinese Individuals. Wen, S., Gong, M., Wang, T., et al.[2023]

Retatrutide, a triple agonist targeting incretin receptors, has shown significant weight loss and reductions in glycated hemoglobin (HbA1c) in phase-2 trials for individuals with type 2 diabetes mellitus (T2DM), as well as substantial weight loss in non-T2DM individuals, although gastrointestinal side effects were noted.

Concerns about cardiovascular safety have emerged due to dose-dependent increases in heart rate and mild to moderate cardiac arrhythmias, highlighting the need for long-term cardiovascular outcome trials to assess its safety in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retatrutide: a triple incretin receptor agonist for obesity management. Ray, A.[2023]

HSG4112, an optimized analog of glabridin, was found to be more effective and stable than glabridin in promoting weight loss in obese mice, demonstrating significant improvements in obesity-related parameters after six weeks of treatment.

The weight loss effects of HSG4112 were primarily due to increased energy expenditure rather than reduced physical activity or food intake, indicating a potential mechanism of action that enhances metabolic rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery and preclinical efficacy of HSG4112, a synthetic structural analog of glabridin, for the treatment of obesity. Choi, LS., Jo, IG., Kang, KS., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Accumulating Data to Optimally Predict Obesity Treatment (ADOPT): Recommendations from the Biological Domain. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Multidisciplinary residential program for the treatment of obesity: how body composition assessed by DXA and blood chemistry parameters change during hospitalization and which variations in body composition occur from discharge up to 1-year follow-up. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Rapid Changes in Bodyweight and Glycemic Control Are Determined by Pre-status After Bariatric Surgery in Both Genders in Young Chinese Individuals. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A comparison of maintenance-tailored therapy (MTT) and standard behavior therapy (SBT) for the treatment of obesity. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Retatrutide: a triple incretin receptor agonist for obesity management. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Reverse gastric pacing reduces food intake without inducing symptoms in dogs. [2005]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The appropriate remodeling of extracellular matrix is the key molecular signature in subcutaneous adipose tissue following Roux-en-Y gastric bypass. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Discovery and preclinical efficacy of HSG4112, a synthetic structural analog of glabridin, for the treatment of obesity. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Changes of Resting Energy Expenditure in Type 2 Diabetes Rats After Roux-en-Y Gastric Bypass. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Roux-en-Y gastric bypass enhances energy expenditure and extends lifespan in diet-induced obese rats. [2021]