Comparing Elecoglipron with Semaglutide for type 2 diabetes mellitus
Official title: 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
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)
Interventions
Elecoglipron
Elecoglipron is administered orally once daily.
Semaglutide
Semaglutide is administered orally once daily.
Canadian Sites (10)
Research Site
Vancouver, British Columbia, Canada
Research Site
Guelph, Ontario, Canada
Research Site
Sarnia, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
Stouffville, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Saint-Charles-Borromée, Quebec, Canada
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)
- +Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s)
- +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
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Elecoglipron, Semaglutide.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,200 people.
The study is currently expected to finish around May 2028.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 52.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in Hemoglobin A1c (HbA1c) — measured over Baseline to Week 52.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07662213 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ElecoglipronDrug
Elecoglipron is administered orally once daily.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About SemaglutideDrug
Semaglutide is administered orally once daily.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to Week 52.
The study as a whole is currently expected to finish around 2028-05-23.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,200 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Vancouver, British Columbia, Canada; Guelph, Ontario, Canada; Sarnia, Ontario, Canada; Scarborough Village, Ontario, Canada; Stouffville, Ontario, Canada; Toronto, Ontario, Canada, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (5)
Research Site
Southfield, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Renton, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.