A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM

NCT07667803
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
4,500
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Lead sponsor
AstraZeneca
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Start date
2026-06-29
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Number of sites
325
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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).
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Acronym
Embold
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Short title
A Master Protocol to Investigate Efficacy and Safety of Elecoglipron in Participants With Obesity or Overweight With or Without T2DM
clinicaltrials.gov
Official title
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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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-07-30
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First posted
2026-06-25
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Registry last updated
2026-10-13
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Primary completion date
2028-07-31
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Start date
2026-06-29
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Participants
4,500
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Participant count basis
Estimated
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Planned participants
4,500
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Protocol amendments
0
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Number of sites
325
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07667803
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ClinicalTrials.gov ID
NCT07667803
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent body weight loss

    Timeframe: 72 weeks

    Percent change from baseline to Week 72 in body weight

  1. Absolute body weight loss

    Timeframe: 72 weeks

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

  2. Total body weight loss of at least 5%, 10%, and 15%

    Timeframe: 72 weeks

    * 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

  3. Percent body weight loss in participants with body mass index (BMI) ≥ 27 kg/m2 at baseline

    Timeframe: 72 weeks

    Percent change from baseline to Week 72 in body weight

  4. Waist circumference reduction

    Timeframe: 72 weeks

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

  5. Glycemic control

    Timeframe: 72 weeks

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

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

    Timeframe: 72 weeks

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

  7. Study 2 only: Achieving glycemic control in participants with HbA1c ≥ 7.0% (53 mmol/mol) at baseline

    Timeframe: 72 weeks

    * Achieved HbA1c \< 7.0% (53 mmol/mol) at Week 72 * Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 72

  8. Systolic blood pressure reduction

    Timeframe: 72 weeks

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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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

Sources for eligibility
clinicaltrials.gov

  • Research SiteBirmingham, United StatesRecruiting
  • Research SiteDothan, United StatesRecruiting
  • Research SiteChandler, United StatesRecruiting
  • Research SiteSun City, United StatesNot yet recruiting
  • Research SiteLittle Rock, United StatesRecruiting
  • Research SiteLynwood, United StatesRecruiting
  • Research SiteRolling Hills Estates, United StatesRecruiting
  • Research SiteSacramento, United StatesRecruiting
  • Research SiteArvada, United StatesRecruiting
  • Research SiteNew Haven, United StatesNot yet recruiting
  • Research SitePlantation, United StatesNot yet recruiting
  • Research SiteTampa, United StatesRecruiting
  • Research SiteWoodstock, United StatesRecruiting
  • Research SiteAmmon, United StatesRecruiting
  • Research SiteMelrose Park, United StatesRecruiting
  • Research SiteIndianapolis, United StatesRecruiting
  • Research SiteWichita, United StatesRecruiting
  • Research SiteLouisville, United StatesRecruiting
  • Research SiteAlexandria, United StatesRecruiting
  • Research SiteBaltimore, United StatesNot yet recruiting
  • Research SitePotomac, United StatesRecruiting
  • Research SiteWhite Marsh, United StatesRecruiting
  • Research SiteYpsilanti, United StatesWithdrawn
  • Research SiteRidgeland, United StatesRecruiting
  • Research SiteKansas City, United StatesRecruiting

And 300 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-524688-19
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)