Recruiting NCT07662135

A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin

Phase III Interventional Type 2 Diabetes Mellitus Type 2 Diabetes With Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Elecoglipron, Placebo.
Who it may be relevant to: Registry conditions: Type 2 Diabetes Mellitus, Type 2 Diabetes With Chronic Kidney Disease. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Bulgaria, China, Denmark, Germany +11
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)

Overview

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Interventions

Drug Elecoglipron
Elecoglipron is administered orally once daily.
Drug Placebo
Placebo is administered orally once daily.

Primary outcome measures

Change from baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline to Week 40]

Secondary outcome measures (9)

Achievement of HbA1c < 7% (53 mmol/mol) [Time frame: Week 40]
Achievement of HbA1c ≤ 6.5% (48 mmol/mol) [Time frame: Week 40]
Percent change in body weight [Time frame: Baseline to Week 40]
Change from baseline in body weight [Time frame: Baseline to Week 40]
Change from baseline in Systolic Blood Pressure (SBP) [Time frame: Baseline to Week 40]
Achievement of HbA1c < 7% (53 mmol/mol) without hypoglycemia (glucose < 54 mg/dL (3.0 mmol/L) or severe hypoglycemia) [Time frame: Baseline to Week 40]
Change from baseline in Fasting Plasma Glucose (FPG) [Time frame: Baseline to Week 40]
Time to initiation of rescue medication over 40 weeks [Time frame: Baseline to Week 40]
Change from baseline in Diastolic Blood Pressure (DBP) [Time frame: Baseline to Week 40]

Eligibility criteria

Inclusion criteria

Diagnosed with Type 2 Diabetes Mellitus for at least 90 days prior to screening
On SGTL2i or SGLT2i-naïve and other glucose lowering medication(s)
HbA1c value:

On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol)
SGLT2i-naive ≥ 7.5% to ≤ 10.5% (58 to 91.3 mmol/mol)
Impaired renal function
Body mass index (BMI) of ≥ 23 kg/m2 at screening
Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion criteria

Type 1 Diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
History of acute or chronic pancreatitis
Severe congestive heart failure (New York Heart Association IV)
History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 33 centers

Research Site — Peoria
Research Site — Surprise
Research Site — Concord
Research Site — Sacramento
Research Site — Victorville
Research Site — Fleming Island
Research Site — Lauderdale Lakes
Research Site — Leesburg
… and 25 more centers

Germany · 18 centers

Research Site — Bad Oeynhausen
Research Site — Berlin
Research Site — Brandenburg an der Havel
Research Site — Chemnitz
Research Site — Duisburg
Research Site — Duisburg
Research Site — Erlangen
Research Site — Frankfurt
… and 10 more centers

Japan · 16 centers