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

Phase 2TerminatedNCT05297045

Regor Pharmaceuticals Inc.17 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

RGT001-075DRUG

Oral GLP1 Receptor Agonist

PlaceboOTHER

Placebo comparator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Axon Clinical Research

Doral, Florida, United States

Outcomes

Primary Outcomes

Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population

Time frame: up to 16 weeks

Secondary Outcomes

Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population

Time frame: up to 16 weeks

Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population

Time frame: up to 16 weeks

Change in body mass index from baseline to end of treatment in the modified intent-to-treat population

Time frame: up to 16 weeks

Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population

Time frame: up to 16 weeks

Change in mean blood lipids including triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline to end of treatment in the modified intent-to-treat population

Time frame: up to 16 weeks

Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0%

Time frame: up to 16 weeks

Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss

Time frame: up to 16 weeks

Incidence of treatment-emergent adverse events (TEAE)s, serious adverse events (SAE)s, deaths, and adverse events (AE)s leading to study discontinuation

Time frame: up to 16 weeks

Data from ClinicalTrials.gov

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