A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus
A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)
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
The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening * T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * 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 (27)
AL
- Research Site · Birmingham, AL 35233More trials in Birmingham
- Research Site · Daphne, AL 36526More trials in Daphne
CA
- Research Site · Lomita, CA 90717More trials in Lomita
- Research Site · Los Alamitos, CA 90720More trials in Los Alamitos
- Research Site · San Diego, CA 92111More trials in San Diego
- Research Site · Walnut Creek, CA 94598More trials in Walnut Creek
CO
- Research Site · Englewood, CO 80110More trials in Englewood
CT
- Research Site · Bridgeport, CT 06606More trials in Bridgeport
FL
- Research Site · Jacksonville, FL 32256More trials in Jacksonville
- Research Site · Orlando, FL 32801More trials in Orlando
GA
- Research Site · Conyers, GA 30094More trials in Conyers
- Research Site · Decatur, GA 30030More trials in Decatur
- Research Site · Hinesville, GA 31313More trials in Hinesville
KS
- Research Site · El Dorado, KS 67042More trials in El Dorado
- Research Site · Newton, KS 67114More trials in Newton
KY
- Research Site · Lexington, KY 40509More trials in Lexington
LA
- Research Site · Covington, LA 70433More trials in Covington
MD
- Research Site · Bowie, MD 20715More trials in Bowie
MI
- Research Site · Southfield, MI 48075More trials in Southfield
MO
- Research Site · Kansas City, MO 64111More trials in Kansas City
- Research Site · St Louis, MO 63141More trials in St Louis
NV
- Research Site · Las Vegas, NV 89119More trials in Las Vegas
SC
- Research Site · Anderson, SC 29621More trials in Anderson
TN
- Research Site · Knoxville, TN 37909More trials in Knoxville
TX
- Research Site · Fort Worth, TX 76135More trials in Fort Worth
- Research Site · Irving, TX 75061More trials in Irving
WA
- Research Site · Renton, WA 98057More trials in Renton