RGT001-075 for Obesity

(COMO-1 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RGT001-075, a potential weight loss drug, to determine its effectiveness in aiding weight loss for individuals who are obese or overweight with related health issues. Participants will receive either the study drug at varying doses or a placebo (a harmless pill with no active ingredient) for 36 weeks. The trial aims to assess the drug's safety and effectiveness in promoting weight loss. It seeks adults with a BMI of 30 or higher, or a BMI between 27 and 30 accompanied by conditions like high blood pressure or sleep apnea. Participants should have maintained a stable weight for the past three months and not have recently used weight loss drugs. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that RGT001-075 is likely to be safe for humans?

Research has shown that RGT001-075 has undergone testing to evaluate its safety and tolerability in individuals with obesity. In these studies, participants took the drug, and researchers observed their bodily responses. The results indicated that RGT001-075 was generally well-tolerated, with most participants not experiencing serious side effects. Some reported mild to moderate side effects, but these were not serious enough to cause major concern.

RGT001-075 remains under investigation in clinical trials, as researchers continue to gather more data to ensure its safety for everyone. Prospective trial participants may find this information helpful in understanding what to expect regarding safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about RGT001-075 for obesity because it offers a fresh approach compared to typical treatments like lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as semaglutide. RGT001-075 is unique as it targets obesity with a potentially novel mechanism or ingredient, which might enhance weight loss more effectively or with fewer side effects. Unlike existing options that may take weeks to show significant impact, RGT001-075 could provide noticeable results faster, making it an appealing alternative for individuals struggling with weight management.

What evidence suggests that RGT001-075 might be an effective treatment for obesity?

Research has shown that RGT001-075 may aid in weight loss. In earlier studies, participants taking RGT001-075 lost a noticeable amount of weight after 36 weeks. This trial will test different doses of RGT001-075 to evaluate its effectiveness and safety. The treatment helps control appetite and blood sugar levels. Early results suggest it is safe and easy to tolerate. Overall, RGT001-075 could be a good option for individuals dealing with obesity or being overweight with related health issues. ^{1 4 5 6 7}

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

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06277934

NCT06277934 | A Study of RGT001-075 in Participants ... A Study of RGT001-075 in Participants With Obesity or Overweight With Weight-Related Comorbidities. ClinicalTrials.gov ID NCT06277934. Sponsor Regor ...

2. prnewswire.com prnewswire.com/news-releases/regor-releases-phase-2a-topline-results-for-rgt-075-an-oral-once-daily-small-molecule-glp-1r-agonist-and-begins-phase-2b-study-in-the-us-for-the-treatment-of-obesity-302348153.html

Regor Releases Phase 2a Topline Results for RGT-075 ... The primary endpoint is percent change in body weight from baseline to week 36. Secondary endpoints include safety and tolerability of the ...

3. endocrinologyadvisor.com endocrinologyadvisor.com/news/clinical-trial-obesity/

Clinical Trial: A Study of RGT001-075 in Adult Patients With ... Clinical Trial: A Study of RGT001-075 in Adult Patients With Obesity. Endocrinology Advisor Staff. |. Publish Date April 12, 2024.

4. withpower.com withpower.com/trial/rgt001-075-for-obesity-a7999

RGT001-075 for Obesity (COMO-1 Trial) An 8-week multidisciplinary residential program (MRP) for obesity led to significant weight loss and improvements in body composition and metabolic parameters ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06867718

NCT06867718 | Study of Once-Daily Oral RGT001-075 ... Study of Once-Daily Oral RGT001-075 Compared With Placebo in Adults With Obesity or Are Overweight With Weight-Related Health Conditions (COMO-1).

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-rgt001-075-in-adult-patients-with-obesity

A Study of RGT001-075 in Participants With Obesity or ... The main purpose of this study was to evaluate the safety and tolerability of RGT001-075 in healthy participants with obesity.

7. prnewswire.com prnewswire.com/news-releases/regor-initiates-phase-2-study-of-oral-once-daily-glp-1-agonist-rgt-075-for-the-treatment-of-obesity-302084213.html

Regor Initiates Phase 2 Study of Oral Once-daily GLP-1 ... "RGT-075 is designed to be administered orally once daily as a monotherapy or as part of a potential oral combination treatment for obesity.