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RecruitingPhase 3

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

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 on Background Insulin (Eluminate-3)

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 (a treatment with no active drug). It is for adults with type 2 diabetes who take insulin and other medicines to lower blood sugar.

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), treated with a background insulin and other background 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.
  • Be on a stable treatment plan with insulin and other blood sugar medicines.
  • Have an HbA1c of 7% to 10.5%. This blood test measures average blood sugar over time.
  • Have a body mass index (BMI) of at least 23 at screening. BMI compares weight with height.
  • Have had a stable body weight for 90 days before screening.

Who can't join

  • Have type 1 diabetes or another form besides type 2, or a history of ketoacidosis (dangerous acid buildup in the blood) or coma from very high blood sugar.
  • Are getting or expect to get treatment for diabetes-related damage or swelling in the back of the eye.
  • 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 serious condition affecting the upper digestive tract, or regularly take medicine that changes how the stomach moves or empties food.
  • Have ever had pancreatitis (swelling of the pancreas).
  • Have the most severe class of heart failure (NYHA class IV).
  • Have a personal or family history of medullary thyroid cancer (a type of 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 T2DM for at least 90 days prior to screening * Stable treatment with background insulin and other background glucose-lowering medication(s) * HbA1c value of ≥ 7% to ≤ 10.5% * 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: * T1DM, 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 (NYHA IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Study sites (17)

AR

CA

CO

FL

GA

MD

NC

NY

SC

TN

TX

WA