NCT07667803ClinicalTrials.gov

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)

RecruitingTaking participants now, according to the registry record.

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In brief

Phase 34,500 participants sought325 sites19 countries

Registered in 1 registry

ClinicalTrials.govNCT07667803Open this record at ClinicalTrials.govSynced 2 weeks ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2026-06-25; recorded start 2026-06-29
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding16/20
Triple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 321 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 4,500 participants (target), run at 325 sites, across 19 countries.

How this score is built

Enrolment35/40
4,500 participants (target)
Site count25/25
321 sites
Country count15/15
19 countries
Planned duration8/10
Planned over about 38 months
Sponsor scale10/10
AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

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).

This is a Phase III, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 2 doses of elecoglipron compared with placebo, given once daily as oral tablets. This protocol covers two independent pivotal studies in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 25 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Prediabetes, Dyslipidemia, CV disease and/or Obstructive sleep apnea) without T2DM (Study 1) and as well as those who are living with obesity or overweight with T2DM (Study 2). Approximately 3000 participants will be randomized in the study 1 and 1500 participants in the study 2. The primary endpoint is percent change in body weight from baseline at 72 weeks.

Conditions

Weight Management

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria * Legal age of consent and at least 18 years old * Study 1 - * 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 visit * 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 Criteria * Study 1 - Established diagnosis of T1DM or T2DM. * Study 2 - Any of the following medical history, laboratory values, or complications related to diabetes: * T1DM * 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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	TRIPLE (3)
Enrolment	4,500 participants sought

Sponsor and collaborators

AstraZeneca Sponsor

Arms and interventions

Arm 1 - Dose 1EXPERIMENTAL
Active IMP
Arm 2 - Dose 2EXPERIMENTAL
Active IMP
Arm 3 - PlaceboPLACEBO_COMPARATOR
Placebo matching elecoglipron

Interventions

Drug Elecoglipron
Elecoglipron film-coated tablet once daily
Drug Placebo
Placebo matching elecoglipron film-coated tablet once daily

Outcome measures

Primary outcome
Percent body weight loss
Percent change from baseline to Week 72 in body weight
Time frame 72 weeks
Secondary outcome
Absolute body weight loss
Absolute change from baseline to Week 72 in body weight (kg)
Time frame 72 weeks
Secondary outcome
Total body weight loss of at least 5%, 10%, and 15%
* Achieved ≥ 5% body weight loss from baseline at Week 72 * Achieved ≥ 10% body weight loss from baseline at Week 72 * Achieved ≥ 15% body weight loss from baseline at Week 72
Time frame 72 weeks
Secondary outcome
Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline
Percent change from baseline to Week 72 in body weight
Time frame 72 weeks
Secondary outcome
Waist circumference reduction
Absolute change from baseline to Week 72 in waist circumference (cm)
Time frame 72 weeks
Secondary outcome
Glycemic control
Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)
Time frame 72 weeks
Secondary outcome
Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline
Achieved normoglycemia (HbA1c \< 5.7% \[39 mmol/mol\]) at Week 72
Time frame 72 weeks
Secondary outcome
Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline
* Achieved HbA1c \< 7.0% (53 mmol/mol) at Week 72 * Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72
Time frame 72 weeks
Secondary outcome
Systolic blood pressure reduction
Change from baseline to Week 72 in systolic blood pressure (mmHg)
Time frame 72 weeks

Dates

Dates
Start date	June 29, 2026 (actual)
Primary completion	July 31, 2028 (estimated)
Completion	July 30, 2029 (estimated)
First posted	June 25, 2026 (actual)
Last updated	September 9, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

109 sites are recruiting

Argentina

Argentina
Facility	City	Status
Research Site	Buenos Aires	Recruiting
Research Site	Buenos Aires	Recruiting
Research Site	CABA	Not yet recruiting
Research Site	CABA	Recruiting
Research Site	Caba	Recruiting
Research Site	Capital Federal	Recruiting
Research Site	Granadero Baigorria	Not yet recruiting
Research Site	Lanus	Not yet recruiting
Research Site	Rosario	Recruiting
Research Site	Rosario	Not yet recruiting
Research Site	San Nicolás	Not yet recruiting
Research Site	San Vicente	Not yet recruiting

Australia

Australia
Facility	City	Status
Research Site	Botany	Recruiting
Research Site	Camberwell	Recruiting
Research Site	Charlestown	Recruiting
Research Site	Maroubra	Recruiting
Research Site	St Albans	Recruiting
Research Site	St Leonards	Recruiting

Brazil

Brazil
Facility	City	Status
Research Site	Belém	Not yet recruiting
Research Site	Brasília	Not yet recruiting
Research Site	Campinas	Not yet recruiting
Research Site	Campinas	Not yet recruiting
Research Site	Curitiba	Not yet recruiting
Research Site	Fortaleza	Not yet recruiting
Research Site	Porto Alegre	Not yet recruiting
Research Site	São José dos Campos	Not yet recruiting
Research Site	São Paulo	Not yet recruiting
Research Site	São Paulo	Not yet recruiting
Research Site	São Paulo	Not yet recruiting

Canada

Canada
Facility	City	State or region	Status
Research Site	Brampton	Ontario	Recruiting
Research Site	Calgary	Alberta	Recruiting
Research Site	Calgary	Alberta	Not yet recruiting
Research Site	Hamilton	Ontario	Recruiting
Research Site	Joliette	Quebec	Recruiting
Research Site	Moncton	New Brunswick	Recruiting
Research Site	Montreal	Quebec	Recruiting
Research Site	Niagara Falls	Ontario	Recruiting
Research Site	North York	Ontario	Recruiting
Research Site	Saint-Lambert	Quebec	Recruiting
Research Site	Sarnia	Ontario	Recruiting
Research Site	Scarborough Village	Ontario	Recruiting
Research Site	Stouffville	Ontario	Recruiting
Research Site	Terrebonne	Quebec	Recruiting
Research Site	Toronto	Ontario	Recruiting
Research Site	Toronto	Ontario	Recruiting
Research Site	Toronto	Ontario	Recruiting
Research Site	Truro	Nova Scotia	Recruiting
Research Site	Vancouver	British Columbia	Recruiting
Research Site	Victoria	British Columbia	Recruiting

Chile

Chile
Facility	City	State or region	Status
Research Site	Araucania		Not yet recruiting

275 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 9, 2026
Site added
4 sites added (325 total)
321325

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07667803

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Argentina

Australia

Brazil

Canada

Chile

Study documents

Changes over time