Testing Elecoglipron against a placebo for weight management
Official title: A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (Embold)
- Phase 3
- 3 groups
- Sites in Calgary, Vancouver and 14 more cities
- Recruiting
Interventions
- Medication
Elecoglipron
Elecoglipron film-coated tablet once daily
- Medication
Placebo
Placebo matching elecoglipron film-coated tablet once daily
Canadian Sites (20)
19 of 20 recruiting
- Recruiting
Research Site
Calgary, Alberta
- Recruiting
Research Site
Vancouver, British Columbia
- Recruiting
Research Site
Victoria, British Columbia
- Recruiting
Research Site
Moncton, New Brunswick
- Recruiting
Research Site
Truro, Nova Scotia
- Recruiting
Research Site
Brampton, Ontario
- Recruiting
Research Site
Hamilton, Ontario
- Recruiting
Research Site
Niagara Falls, Ontario
- Recruiting
Research Site
North York, Ontario
- Recruiting
Research Site
Sarnia, Ontario
- Recruiting
Research Site
Scarborough Village, Ontario
- Recruiting
Research Site
Stouffville, Ontario
- Recruiting
Research Site
Toronto, Ontario
- Recruiting
Research Site
Toronto, Ontario
- Recruiting
Research Site
Toronto, Ontario
- Recruiting
Research Site
Joliette, Quebec
- Recruiting
Research Site
Montreal, Quebec
- Recruiting
Research Site
Saint-Lambert, Quebec
- Recruiting
Research Site
Terrebonne, Quebec
- Not yet recruiting
Research Site
Calgary, Alberta
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Legal age of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and at least 18 years old
- +BMI ≥ 30 kg/m2 or
- +25 kg/m2 ≤ BMI \< 30 kg/m2 with at least one of the following weight-related comorbidities:
- +Hypertension
- +Prediabetes
- +Dyslipidemia
- +Cardiovascular disease
- +Obstructive sleep apnea.
- +Study 2 - BMI ≥ 25 kg/m2 and T2DM defined as below:
- +Established diagnosis of T2DM
- +Without established diagnosis of T2DM and HbA1c ≥ 6.5% (48 mmol/mol) at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →
- +Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)
- +History of at least one self-reported unsuccessful dietary effort to lose body weight.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Study 1 - Established diagnosis of T1DM or T2DM.
- +Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
- +HbA1c ≥ 10% (86 mmol/mol) at the screening visit
- +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 the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- +History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
- +History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2
Exclusion
- −Study 1 - Established diagnosis of T1DM or T2DM.
- −Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes:
- −HbA1c ≥ 10% (86 mmol/mol) at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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 the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- −History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis
- −History/family history (first degree biologic relatives) 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.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A and B receive Elecoglipron.
Registry label: A: Arm 1 - Dose 1 · B: Arm 2 - Dose 2
Group C, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: C: Arm 3 - Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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 4,500 people.
The study is currently expected to finish around July 2029.
The main measurement is taken over: 72 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percent body weight loss — measured over 72 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07667803 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 film-coated tablet 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 PlaceboDrug
Placebo matching elecoglipron film-coated tablet 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?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
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: 72 weeks.
The study as a whole is currently expected to finish around 2029-07-30.
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 4,500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 21 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada; Moncton, New Brunswick, Canada; Truro, Nova Scotia, Canada; Brampton, Ontario, Canada, and 15 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
This master study protocol, Study D7260C00015, covers 2 independent, pivotal studies, Study 1 and Study 2. Each study is a global, randomized, double-blind, parallel-group, multicenter, Phase III study to assess the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adults living with obesity or overweight with at least one weight-related comorbidity, and without T2DM (Study 1) or with T2DM (Study 2).
Other Sites (4)
Research Site
Ypsilanti, Michigan, United States
Research Site
Albany, New York, United States
Research Site
Laurelton, New York, United States
Research Site
Long Island City, New York, 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.