Recruiting NCT07662213

A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

Phase III Interventional Type 2 Diabetes Mellitus

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, Semaglutide.
Who it may be relevant to: Registry conditions: Type 2 Diabetes Mellitus. 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, Argentina, Australia, Brazil, Bulgaria +10
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, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Oral Semaglutide in Adults With Type 2 Diabetes Mellitus (Eluminate-2)

Overview

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

Interventions

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

Primary outcome measures

Change from baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline to Week 52]

Secondary outcome measures (7)

Percent change from baseline to Week 52 in body weight [Time frame: Baseline to Week 52]
Change from baseline to Week 52 in body weight (kg) [Time frame: Baseline to Week 52]
Achieved ≥ 5% weight loss from baseline at Week 52 and achieved HbA1c < 7% (53 mmol/mol) at Week 52 [Time frame: Baseline to Week 52]
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 52 [Time frame: Week 52]
Achieved HbA1c < 7% (53 mmol/mol) at Week 52 [Time frame: Week 52]
Achieved ≥ 5% weight loss from baseline at Week 52 [Time frame: Baseline to Week 52]
Change from baseline to Week 52 in Systolic Blood Pressure (BP) and Diastolic BP [Time frame: Baseline to Week 52]

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(s)
HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors
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 Mellitus (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 Gastrointestinal (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

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: Open label
Primary purpose: Treatment