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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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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…

Phase 34.500 Teilnehmende gesucht325 Studienzentren19 Länder

Kategorien

Endokrin und metabolisch100%

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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.

Zusammenfassung

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.

Erkrankungen

  • Weight Management

Eignung

GeschlechtAlle
Alter18 Years – Kein Höchstalter
Gesunde FreiwilligeNein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

StudientypInterventionell
PhasePhase 3
ZuteilungRandomisiert
InterventionsmodellPARALLEL
Primäres ZielTREATMENT
VerblindungTRIPLE (3)
Teilnahme4.500 Teilnehmende gesucht

Sponsor und Mitwirkende

  • AstraZeneca Sponsor

Studienarme und Interventionen

  • Arm 1 - Dose 1EXPERIMENTAL

    Active IMP

  • Arm 2 - Dose 2EXPERIMENTAL

    Active IMP

  • Arm 3 - PlaceboPLACEBO_COMPARATOR

    Placebo matching elecoglipron

Interventionen

  • Arzneimittel Elecoglipron

    Elecoglipron film-coated tablet once daily

  • Arzneimittel Placebo

    Placebo matching elecoglipron film-coated tablet once daily

Endpunkte

  1. Primärer Endpunkt

    Percent body weight loss

    Percent change from baseline to Week 72 in body weight

    Zeitrahmen 72 weeks

  2. Sekundärer Endpunkt

    Absolute body weight loss

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

    Zeitrahmen 72 weeks

  3. Sekundärer Endpunkt

    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

    Zeitrahmen 72 weeks

  4. Sekundärer Endpunkt

    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

    Zeitrahmen 72 weeks

  5. Sekundärer Endpunkt

    Waist circumference reduction

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

    Zeitrahmen 72 weeks

  6. Sekundärer Endpunkt

    Glycemic control

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

    Zeitrahmen 72 weeks

  7. Sekundärer Endpunkt

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

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

    Zeitrahmen 72 weeks

  8. Sekundärer Endpunkt

    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

    Zeitrahmen 72 weeks

  9. Sekundärer Endpunkt

    Systolic blood pressure reduction

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

    Zeitrahmen 72 weeks

Daten

Startdatum29. Juni 2026 (tatsächlich)
Primärer Abschluss31. Juli 2028 (geschätzt)
Abschluss30. Juli 2029 (geschätzt)
Erstveröffentlichung25. Juni 2026 (tatsächlich)
Zuletzt aktualisiert9. September 2026
Ergebnisse veröffentlichtIm Registereintrag nicht angegeben
Status zuletzt bestätigtSeptember 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

109 Studienzentren rekrutieren

Argentina

EinrichtungStadtBundesland oder RegionStatus
Research SiteBuenos AiresRekrutiert
Research SiteBuenos AiresRekrutiert
Research SiteCABARekrutierung noch nicht begonnen
Research SiteCABARekrutiert
Research SiteCabaRekrutiert
Research SiteCapital FederalRekrutiert
Research SiteGranadero BaigorriaRekrutierung noch nicht begonnen
Research SiteLanusRekrutierung noch nicht begonnen
Research SiteRosarioRekrutiert
Research SiteRosarioRekrutierung noch nicht begonnen
Research SiteSan NicolásRekrutierung noch nicht begonnen
Research SiteSan VicenteRekrutierung noch nicht begonnen

Australia

EinrichtungStadtBundesland oder RegionStatus
Research SiteBotanyRekrutiert
Research SiteCamberwellRekrutiert
Research SiteCharlestownRekrutiert
Research SiteMaroubraRekrutiert
Research SiteSt AlbansRekrutiert
Research SiteSt LeonardsRekrutiert

Brazil

EinrichtungStadtBundesland oder RegionStatus
Research SiteBelémRekrutierung noch nicht begonnen
Research SiteBrasíliaRekrutierung noch nicht begonnen
Research SiteCampinasRekrutierung noch nicht begonnen
Research SiteCampinasRekrutierung noch nicht begonnen
Research SiteCuritibaRekrutierung noch nicht begonnen
Research SiteFortalezaRekrutierung noch nicht begonnen
Research SitePorto AlegreRekrutierung noch nicht begonnen
Research SiteSão José dos CamposRekrutierung noch nicht begonnen
Research SiteSão PauloRekrutierung noch nicht begonnen
Research SiteSão PauloRekrutierung noch nicht begonnen
Research SiteSão PauloRekrutierung noch nicht begonnen

Canada

EinrichtungStadtBundesland oder RegionStatus
Research SiteBramptonOntarioRekrutiert
Research SiteCalgaryAlbertaRekrutiert
Research SiteCalgaryAlbertaRekrutierung noch nicht begonnen
Research SiteHamiltonOntarioRekrutiert
Research SiteJolietteQuebecRekrutiert
Research SiteMonctonNew BrunswickRekrutiert
Research SiteMontrealQuebecRekrutiert
Research SiteNiagara FallsOntarioRekrutiert
Research SiteNorth YorkOntarioRekrutiert
Research SiteSaint-LambertQuebecRekrutiert
Research SiteSarniaOntarioRekrutiert
Research SiteScarborough VillageOntarioRekrutiert
Research SiteStouffvilleOntarioRekrutiert
Research SiteTerrebonneQuebecRekrutiert
Research SiteTorontoOntarioRekrutiert
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Research SiteTorontoOntarioRekrutiert
Research SiteTruroNova ScotiaRekrutiert
Research SiteVancouverBritish ColumbiaRekrutiert
Research SiteVictoriaBritish ColumbiaRekrutiert

Chile

EinrichtungStadtBundesland oder RegionStatus
Research SiteAraucaniaRekrutierung noch nicht begonnen

275 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

  1. 9. September 2026

    Studienzentrum hinzugefügt

    4 sites added (325 total)

    321325

Register: ClinicalTrials.gov · NCT########

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