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

NCT05297045 | Terminated Phase 2 FDA Drug

• 1 other identifier: RGT001-075_01-201
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  up to 16 weeks

Secondary Outcomes (37)

• 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

Study Arms (7)

Dose Group A

EXPERIMENTAL

Drug: RGT001-075

Dose Group B

EXPERIMENTAL

Drug: RGT001-075

Dose Group C

EXPERIMENTAL

Drug: RGT001-075

Dose Group D

EXPERIMENTAL

Drug: RGT001-075

Dose Group E

EXPERIMENTAL

Drug: RGT001-075

Dose Group F

EXPERIMENTAL

Drug: RGT001-075

Placebo Group

PLACEBO COMPARATOR

Other: Placebo

Interventions

RGT001-075 DRUG

Oral GLP1 Receptor Agonist

Dose Group A; Dose Group B; Dose Group C; Dose Group D; Dose Group E; Dose Group F

Placebo OTHER

Placebo comparator

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regor Pharmaceuticals Inc.: lead

Study Sites (1)

Axon Clinical Research

Doral, Florida, 33166, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 25, 2022
• Study Start: March 29, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

US (1)