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

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

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 Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Placebo; Drug: RGT001-075

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Doral, Florida, United States, 33166
      • Axon Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Other: Placebo; Placebo comparator
Experimental: Dose Group A	Drug: RGT001-075; Oral GLP1 Receptor Agonist
Experimental: Dose Group B	Drug: RGT001-075; Oral GLP1 Receptor Agonist
Experimental: Dose Group C	Drug: RGT001-075; Oral GLP1 Receptor Agonist
Experimental: Dose Group D	Drug: RGT001-075; Oral GLP1 Receptor Agonist
Experimental: Dose Group E	Drug: RGT001-075; Oral GLP1 Receptor Agonist
Experimental: Dose Group F	Drug: RGT001-075; Oral GLP1 Receptor Agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population	up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population	up to 16 weeks
Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population	up to 16 weeks
Change in body mass index from baseline to end of treatment in the modified intent-to-treat population	up to 16 weeks
Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population	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	up to 16 weeks
Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0%	up to 16 weeks
Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss	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	up to 16 weeks
Vital signs - Systolic blood pressure (mmHg) absolute change from baseline	up to 16 weeks
Vital signs - Diastolic blood pressure (mmHg) absolute change from baseline	up to 16 weeks
Vital signs - Heart rate (beats/minute) absolute change from baseline	up to 16 weeks
Vital signs - Body weight (kg) absolute and percent change from baseline	up to 16 weeks
Safety clinical laboratories - complete blood count absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum sodium absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum potassium absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum total bilirubin absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum direct bilirubin absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum alkaline phosphatase absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum alanine aminotransferase absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum aspartate aminotransferase absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum blood urea nitrogen absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum creatinine absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum uric acid absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum calcium absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum lipase absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum amylase absolute change from baseline	up to 16 weeks
Safety clinical laboratories - eGFR (calculated) absolute change from baseline	up to 16 weeks
Safety clinical laboratories - fasting serum glucose absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum albumin absolute change from baseline	up to 16 weeks
Safety clinical laboratories - serum total protein absolute change from baseline	up to 16 weeks
Safety clinical laboratories - fasting serum total cholesterol absolute change from baseline	up to 16 weeks
Safety clinical laboratories - fasting serum triglycerides absolute and percent change from baseline	up to 16 weeks
Safety clinical laboratories - fasting serum HDL-C absolute and percent change from baseline	up to 16 weeks
Safety clinical laboratories - fasting serum LDL-C absolute and percent change from baseline	up to 16 weeks
Safety clinical laboratories - serum calcitonin absolute change from screening	up to 16 weeks
ECG interval change from baseline absolute and categorical outliers >450ms	up to 16 weeks
Proportion of patients who report AEs of Special Interest (AESI) including GI intolerability, hypoglycemia, drug hypersensitivity reactions, acute pancreatitis, thyroid C-cell hyperplasia and C-cell neoplasms, and cardiovascular (CV) events	up to 16 weeks

Collaborators and Investigators

• Sponsor: Regor Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RGT001-075_01-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No