Status:
TERMINATED
A Study of Oral GLP1RA RGT001-075 in Adults With Type 2 Diabetes
Lead Sponsor:
Regor Pharmaceuticals Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 double-blind treatment as determined by mean c...
Eligibility Criteria
Inclusion
- 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
- Screening HbA1c 7.0-10.5%
- Male or female, age 18-75 years
- Screening BMI 24.5 - 40 kg/m2
- 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
Exclusion
- Has received within the preceding 3 months prior to Screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor \[DPP-4i\], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy
- 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 any history of myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to Screening
- Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
- Has active proliferative diabetic retinopathy or macular edema
- 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
- Has evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening
- Has had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening
- Has been treated or plan to be treated with drugs or devices or surgery that promote weight loss within 3 months prior to screening
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05297045
Start Date
March 29 2022
End Date
May 30 2023
Last Update
November 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Axon Clinical Research
Doral, Florida, United States, 33166