A Study of Oral GLP1RA RGT001-075 in Adults With Type 2 Diabetes

Regor Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: RGT001-075; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05297045

RGT001-075_01-201

Details and patient eligibility

About

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 change from baseline in HbA1c in adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control with diet and exercise and stable metformin treatment.

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 7 patient groups, including a placebo group

Dose Group A

Experimental group

Treatment:

Drug: RGT001-075

Dose Group B

Experimental group

Treatment:

Drug: RGT001-075

Dose Group C

Experimental group

Treatment:

Drug: RGT001-075

Dose Group D

Experimental group

Treatment:

Drug: RGT001-075

Dose Group E

Experimental group

Treatment:

Drug: RGT001-075

Dose Group F

Experimental group

Treatment:

Drug: RGT001-075

Placebo Group

Placebo Comparator group

Treatment:

Other: Placebo