A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Study of Oral RGT001-075 in Adult Patients With Uncontrollable Type 2 Diabetes Mellitus on Metformin Therapy

Regor Pharmaceuticals Inc.1 site in 1 country17 target enrollmentStarted: March 29, 2022Last updated: November 18, 2023

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Terminated
Sponsor: Regor Pharmaceuticals Inc.
Enrollment: 17
Locations: 1
Primary Endpoint: Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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