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)

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 34500 partecipanti ricercati325 centri19 paesi

Categorie

Endocrino e metabolico100%

Registrato in 1 registro

ClinicalTrials.govNCT07667803Apri questa scheda su ClinicalTrials.govSincronizzato 2 settimane fa

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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.

Sintesi

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.

Patologie

Weight Management

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel registro

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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	TREATMENT
Mascheramento	TRIPLE (3)
Arruolamento	4500 partecipanti ricercati

Sponsor e collaboratori

AstraZeneca Sponsor

Bracci e interventi

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

Interventi

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

Esiti misurati

Esito primario
Percent body weight loss
Percent change from baseline to Week 72 in body weight
Orizzonte temporale 72 weeks
Esito secondario
Absolute body weight loss
Absolute change from baseline to Week 72 in body weight (kg)
Orizzonte temporale 72 weeks
Esito secondario
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
Orizzonte temporale 72 weeks
Esito secondario
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
Orizzonte temporale 72 weeks
Esito secondario
Waist circumference reduction
Absolute change from baseline to Week 72 in waist circumference (cm)
Orizzonte temporale 72 weeks
Esito secondario
Glycemic control
Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)
Orizzonte temporale 72 weeks
Esito secondario
Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline
Achieved normoglycemia (HbA1c \< 5.7% \[39 mmol/mol\]) at Week 72
Orizzonte temporale 72 weeks
Esito secondario
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
Orizzonte temporale 72 weeks
Esito secondario
Systolic blood pressure reduction
Change from baseline to Week 72 in systolic blood pressure (mmHg)
Orizzonte temporale 72 weeks

Date

Date
Data di inizio	29 giugno 2026 (effettiva)
Conclusione primaria	31 luglio 2028 (stimata)
Conclusione	30 luglio 2029 (stimata)
Prima pubblicazione	25 giugno 2026 (effettiva)
Ultimo aggiornamento	9 settembre 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	settembre 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

109 centri stanno reclutando

Argentina

Argentina
Struttura	Città	Stato
Research Site	Buenos Aires	In reclutamento
Research Site	Buenos Aires	In reclutamento
Research Site	CABA	Non ancora in reclutamento
Research Site	CABA	In reclutamento
Research Site	Caba	In reclutamento
Research Site	Capital Federal	In reclutamento
Research Site	Granadero Baigorria	Non ancora in reclutamento
Research Site	Lanus	Non ancora in reclutamento
Research Site	Rosario	In reclutamento
Research Site	Rosario	Non ancora in reclutamento
Research Site	San Nicolás	Non ancora in reclutamento
Research Site	San Vicente	Non ancora in reclutamento

Australia

Australia
Struttura	Città	Stato
Research Site	Botany	In reclutamento
Research Site	Camberwell	In reclutamento
Research Site	Charlestown	In reclutamento
Research Site	Maroubra	In reclutamento
Research Site	St Albans	In reclutamento
Research Site	St Leonards	In reclutamento

Brazil

Brazil
Struttura	Città	Stato
Research Site	Belém	Non ancora in reclutamento
Research Site	Brasília	Non ancora in reclutamento
Research Site	Campinas	Non ancora in reclutamento
Research Site	Campinas	Non ancora in reclutamento
Research Site	Curitiba	Non ancora in reclutamento
Research Site	Fortaleza	Non ancora in reclutamento
Research Site	Porto Alegre	Non ancora in reclutamento
Research Site	São José dos Campos	Non ancora in reclutamento
Research Site	São Paulo	Non ancora in reclutamento
Research Site	São Paulo	Non ancora in reclutamento
Research Site	São Paulo	Non ancora in reclutamento

Canada

Canada
Struttura	Città	Stato o regione	Stato
Research Site	Brampton	Ontario	In reclutamento
Research Site	Calgary	Alberta	In reclutamento
Research Site	Calgary	Alberta	Non ancora in reclutamento
Research Site	Hamilton	Ontario	In reclutamento
Research Site	Joliette	Quebec	In reclutamento
Research Site	Moncton	New Brunswick	In reclutamento
Research Site	Montreal	Quebec	In reclutamento
Research Site	Niagara Falls	Ontario	In reclutamento
Research Site	North York	Ontario	In reclutamento
Research Site	Saint-Lambert	Quebec	In reclutamento
Research Site	Sarnia	Ontario	In reclutamento
Research Site	Scarborough Village	Ontario	In reclutamento
Research Site	Stouffville	Ontario	In reclutamento
Research Site	Terrebonne	Quebec	In reclutamento
Research Site	Toronto	Ontario	In reclutamento
Research Site	Toronto	Ontario	In reclutamento
Research Site	Toronto	Ontario	In reclutamento
Research Site	Truro	Nova Scotia	In reclutamento
Research Site	Vancouver	British Columbia	In reclutamento
Research Site	Victoria	British Columbia	In reclutamento

Chile

Chile
Struttura	Città	Stato o regione	Stato
Research Site	Araucania		Non ancora in reclutamento

Nella scheda del registro sono indicati altri 275 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

9 settembre 2026
Centro aggiunto
4 sites added (325 total)
321325

Registro: ClinicalTrials.gov · NCT########

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