RGT001-075 for Type 2 Diabetes

Overseen By Dawn Begley

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regor Pharmaceuticals Inc.

Must be taking: Metformin

Must not be taking: Sulfonylureas, Insulin, others

Disqualifiers: Active GI disease, Cardiovascular events, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment, RGT001-075, for individuals with type 2 diabetes who do not achieve sufficient results from diet, exercise, and metformin. The goal is to determine how effectively this treatment lowers blood sugar levels compared to a placebo (a harmless pill with no active drug). Participants will be assigned to different groups to receive various doses of the treatment or a placebo. This trial may suit those managing type 2 diabetes with metformin and lifestyle changes but still experiencing high blood sugar. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You can continue taking metformin, but you must stop any other diabetes medications at least 3 months before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RGT001-075 was safe and well-tolerated in past studies. In earlier trials, participants did not report any major safety issues. The treatment was tested on individuals with obesity and was found to be safe.

This is a phase 2 study, indicating that the treatment has already undergone initial safety testing. Early phases check for serious side effects, and reaching phase 2 suggests it is considered safe for a larger group. However, as with any new treatment, unknown side effects may still exist. Always consult a healthcare professional before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

RGT001-075 is unique because it offers an oral delivery method for GLP-1 receptor agonists, which are typically administered through injections. This new approach could greatly improve convenience and adherence for patients with Type 2 diabetes. Additionally, RGT001-075 may have a novel mechanism of action that enhances glucose control and potentially reduces side effects seen with other diabetes medications. Researchers are excited because this could lead to a more accessible and patient-friendly option for managing Type 2 diabetes.

What evidence suggests that RGT001-075 could be an effective treatment for Type 2 Diabetes Mellitus?

Research has shown that RGT001-075, a medication under study in this trial, may help treat Type 2 Diabetes. Similar medications have successfully lowered blood sugar levels in individuals who did not respond well to diet, exercise, and metformin. Early results with RGT001-075 indicate it may also aid in weight management and overall health. This suggests that RGT001-075 could improve blood sugar control in people with Type 2 Diabetes. It mimics a hormone that helps manage insulin and sugar levels in the body. Overall, this supports the idea that RGT001-075 could effectively manage Type 2 Diabetes. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Screening HbA1c 7.0-10.5%

Either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential

Diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of Screening

Exclusion Criteria

Has active GI disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (NASH), Gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis B or C, or primary biliary cirrhosis, or elevated alanine aminotransferase (ALT) levels at Screening

Has 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 cancer

Has an active or untreated malignancy or has been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for <5 years prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral RGT001-075 GLP1 receptor agonist or placebo for up to 16 weeks

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• RGT001-075

How Is the Trial Designed?

Group I: Dose Group F Experimental Treatment 1 Intervention

Group II: Dose Group E Experimental Treatment 1 Intervention

Group III: Dose Group D Experimental Treatment 1 Intervention

Group IV: Dose Group C Experimental Treatment 1 Intervention

Group V: Dose Group B Experimental Treatment 1 Intervention

Group VI: Dose Group A Experimental Treatment 1 Intervention

Group VII: Placebo Group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Regor Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

440+

Published Research Related to This Trial

In a clinical development program involving 1684 subjects and 2038 injections, OptiMARK demonstrated a safety profile comparable to Magnevist, with 31% of its injections associated with adverse events.

OptiMARK was found to be safe and well-tolerated, showing fewer adverse events compared to Magnevist (35%) and placebo (48%), indicating its potential as a reliable imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. Brown, JJ., Kristy, RM., Stevens, GR., et al.[2019]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

In a pilot study at a Veterans Health Administration facility, the Global Trigger Tool (GTT) identified 109 adverse events (AEs) from 273 reviewed medical records, revealing that 21% of hospitalizations were associated with an AE.

Most AEs detected by the GTT (88%) were not found through existing surveillance methods, indicating that the GTT can uncover previously undetected safety issues and enhance quality improvement efforts in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Previously Undetected Harm: Piloting the Institute for Healthcare Improvement's Global Trigger Tool in the Veterans Health Administration. Mull, HJ., Brennan, CW., Folkes, T., et al.[2018]

Citations

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

NCT06277934 | A Study of RGT001-075 in Participants ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

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

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

3. 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 ... Phase 1 clinical data showed promising exploratory body weight trends despite short treatment duration," added Dr. Grimm. About the RGT-075 ...

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 ... This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05297045

A Study of Oral GLP1RA RGT001-075 in Adults With Type ... This is a phase 2 study designed to evaluate the efficacy of daily (QD) oral RGT001-075 GLP1 receptor agonist relative to placebo after up to 16 weeks of ...

7. 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.

8. withpower.com withpower.com/trial/phase-2-type-2-diabetes-mellitus-2-2022-f765f

A Study of Oral GLP1RA RGT001-075 in Adults With Type ... The research articles provided do not contain specific safety data for the treatment evaluated under the names Placebo, Control, Dummy Treatment, or RGT001-075.