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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)

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En resumen

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…

Fase 34500 participantes buscados325 centros19 países

Categorías

Endocrino y metabólico100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

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

Resumen

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.

Afecciones

  • Weight Management

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el 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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoTRIPLE (3)
Inscripción4500 participantes buscados

Patrocinador y colaboradores

  • AstraZeneca Patrocinador

Grupos e intervenciones

  • Arm 1 - Dose 1EXPERIMENTAL

    Active IMP

  • Arm 2 - Dose 2EXPERIMENTAL

    Active IMP

  • Arm 3 - PlaceboPLACEBO_COMPARATOR

    Placebo matching elecoglipron

Intervenciones

  • Fármaco Elecoglipron

    Elecoglipron film-coated tablet once daily

  • Fármaco Placebo

    Placebo matching elecoglipron film-coated tablet once daily

Variables de resultado

  1. Variable de resultado principal

    Percent body weight loss

    Percent change from baseline to Week 72 in body weight

    Plazo 72 weeks

  2. Variable de resultado secundaria

    Absolute body weight loss

    Absolute change from baseline to Week 72 in body weight (kg)

    Plazo 72 weeks

  3. Variable de resultado secundaria

    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

    Plazo 72 weeks

  4. Variable de resultado secundaria

    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

    Plazo 72 weeks

  5. Variable de resultado secundaria

    Waist circumference reduction

    Absolute change from baseline to Week 72 in waist circumference (cm)

    Plazo 72 weeks

  6. Variable de resultado secundaria

    Glycemic control

    Change from baseline to Week 72 in hemoglobin A1c (HbA1c) (%)

    Plazo 72 weeks

  7. Variable de resultado secundaria

    Achieving normoglycemia in participants with HbA1c ≥ 5.7% (39 mmol/mol) at baseline

    Achieved normoglycemia (HbA1c \< 5.7% \[39 mmol/mol\]) at Week 72

    Plazo 72 weeks

  8. Variable de resultado secundaria

    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

    Plazo 72 weeks

  9. Variable de resultado secundaria

    Systolic blood pressure reduction

    Change from baseline to Week 72 in systolic blood pressure (mmHg)

    Plazo 72 weeks

Fechas

Fecha de inicio29 de junio de 2026 (real)
Finalización principal31 de julio de 2028 (estimada)
Finalización30 de julio de 2029 (estimada)
Primera publicación25 de junio de 2026 (real)
Última actualización9 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

109 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Research SiteBuenos AiresEn reclutamiento
Research SiteBuenos AiresEn reclutamiento
Research SiteCABAAún no recluta
Research SiteCABAEn reclutamiento
Research SiteCabaEn reclutamiento
Research SiteCapital FederalEn reclutamiento
Research SiteGranadero BaigorriaAún no recluta
Research SiteLanusAún no recluta
Research SiteRosarioEn reclutamiento
Research SiteRosarioAún no recluta
Research SiteSan NicolásAún no recluta
Research SiteSan VicenteAún no recluta

Australia

CentroCiudadEstado o regiónEstado
Research SiteBotanyEn reclutamiento
Research SiteCamberwellEn reclutamiento
Research SiteCharlestownEn reclutamiento
Research SiteMaroubraEn reclutamiento
Research SiteSt AlbansEn reclutamiento
Research SiteSt LeonardsEn reclutamiento

Brazil

CentroCiudadEstado o regiónEstado
Research SiteBelémAún no recluta
Research SiteBrasíliaAún no recluta
Research SiteCampinasAún no recluta
Research SiteCampinasAún no recluta
Research SiteCuritibaAún no recluta
Research SiteFortalezaAún no recluta
Research SitePorto AlegreAún no recluta
Research SiteSão José dos CamposAún no recluta
Research SiteSão PauloAún no recluta
Research SiteSão PauloAún no recluta
Research SiteSão PauloAún no recluta

Canada

CentroCiudadEstado o regiónEstado
Research SiteBramptonOntarioEn reclutamiento
Research SiteCalgaryAlbertaEn reclutamiento
Research SiteCalgaryAlbertaAún no recluta
Research SiteHamiltonOntarioEn reclutamiento
Research SiteJolietteQuebecEn reclutamiento
Research SiteMonctonNew BrunswickEn reclutamiento
Research SiteMontrealQuebecEn reclutamiento
Research SiteNiagara FallsOntarioEn reclutamiento
Research SiteNorth YorkOntarioEn reclutamiento
Research SiteSaint-LambertQuebecEn reclutamiento
Research SiteSarniaOntarioEn reclutamiento
Research SiteScarborough VillageOntarioEn reclutamiento
Research SiteStouffvilleOntarioEn reclutamiento
Research SiteTerrebonneQuebecEn reclutamiento
Research SiteTorontoOntarioEn reclutamiento
Research SiteTorontoOntarioEn reclutamiento
Research SiteTorontoOntarioEn reclutamiento
Research SiteTruroNova ScotiaEn reclutamiento
Research SiteVancouverBritish ColumbiaEn reclutamiento
Research SiteVictoriaBritish ColumbiaEn reclutamiento

Chile

CentroCiudadEstado o regiónEstado
Research SiteAraucaniaAún no recluta

En el registro figuran 275 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 9 de septiembre de 2026

    Centro añadido

    4 sites added (325 total)

    321325

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

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