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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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well elecoglipron works and how safe it is compared with a placebo, which has no active drug. It is for adults with type 2 diabetes and reduced kidney function who take or will start dapagliflozin 10 mg and also take other blood sugar medicines.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had type 2 diabetes for at least 90 days before screening.
  • Take other blood sugar medicines, whether or not you already take an SGLT2 inhibitor, a type of diabetes medicine.
  • Have an HbA1c (average blood sugar level) of 7.0%–10.5% if taking a steady dose of an SGLT2 inhibitor, or 7.5%–10.5% if you have not taken one.
  • Have reduced kidney function.
  • Have a body mass index (BMI), a measure based on height and weight, of at least 23 at screening.
  • Have had a steady body weight for 90 days before screening.

Who can't join

  • Have type 1 diabetes or another form of diabetes besides type 2, or have had ketoacidosis (dangerous acid buildup) or a coma from very high blood sugar.
  • Are getting or expect to get treatment for diabetes-related eye damage or swelling in the part of the eye used for sharp vision.
  • Have had more than one severe low blood sugar episode in the past 180 days, or have trouble noticing low blood sugar symptoms.
  • Have a major health problem in the upper digestive tract, or regularly take medicine that affects how food moves through or leaves the stomach.
  • Have ever had pancreatitis, which is swelling of the pancreas.
  • Have severe heart failure, called New York Heart Association class IV.
  • Have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors in hormone-making glands.

Simplified for readability. The official criteria below are what the study team uses.

Official 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: 1. On stable dose of SGLT2i ≥ 7.0 % to ≤ 10.5% (53 to 91.3 mmol/mol) 2. 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

Study sites (33)

AZ

CA

FL

IL

MA

MI

MN

MO

NC

NE

NM

NV

NY

OH

RI

SC

TX

UT

VA