A Study of Oral GLP1RA RGT001-075 in Adults With Type 2 Diabetes
AB
DB
Overseen ByDawn Begley
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regor Pharmaceuticals Inc.
Must be taking: Metformin
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
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.
What safety data exists for the treatment evaluated under different names, including Placebo, Control, Dummy Treatment, RGT001-075?
What is the purpose of this trial?
This trial tests a new daily pill for adults with Type 2 Diabetes who can't control their blood sugar with diet, exercise, and metformin. The pill helps manage blood sugar by increasing insulin and reducing sugar production in the liver. This type of medication is known for its glucose-lowering effects and additional benefits such as weight loss and cardiovascular protection.
Eligibility Criteria
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
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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
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Timeline
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
Treatment Details
Interventions
- Placebo
- RGT001-075
Participant Groups
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose Group FExperimental Treatment1 Intervention
Group II: Dose Group EExperimental Treatment1 Intervention
Group III: Dose Group DExperimental Treatment1 Intervention
Group IV: Dose Group CExperimental Treatment1 Intervention
Group V: Dose Group BExperimental Treatment1 Intervention
Group VI: Dose Group AExperimental Treatment1 Intervention
Group VII: Placebo GroupPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regor Pharmaceuticals Inc.
Lead Sponsor
Trials
6
Recruited
440+
Findings from Research
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]
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]
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]
References
The OptiMARK clinical development program: summary of safety data. [2019]
Identifying Previously Undetected Harm: Piloting the Institute for Healthcare Improvement's Global Trigger Tool in the Veterans Health Administration. [2018]
New Associations between Drug-Induced Adverse Events in Animal Models and Humans Reveal Novel Candidate Safety Targets. [2021]
Safety of phase I clinical trials with monoclonal antibodies in Germany--the regulatory requirements viewed in the aftermath of the TGN1412 disaster. [2019]
Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]
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