A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF

NCT07761117
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
6,950
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Lead sponsor
AstraZeneca
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Start date
2026-08-24
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Number of sites
679
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Summary
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
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Acronym
Elevate-HF
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Short title
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
clinicaltrials.gov
Official title
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)
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Control arm
Active comparator
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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
2029-09-03
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First posted
2026-08-12
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Registry last updated
2026-09-28
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Primary completion date
2029-09-03
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Start date
2026-08-24
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Participants
6,950
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Participant count basis
Estimated
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Planned participants
6,950
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Protocol amendments
2
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Number of sites
679
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Data monitoring committee
Yes
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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
NCT07761117
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ClinicalTrials.gov ID
NCT07761117
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Placebo controlled
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit

    Timeframe: Up to 42 months

    Time to first event of the composite of: * CV death * HHF * Urgent HF visit

  1. To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)

    Timeframe: Up to 42 months

    Total occurrences (first and recurrent) of HF events * HHF * Urgent HF visit

  2. To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.

    Timeframe: Baseline and 52 weeks

    Change from baseline to Week 52

  3. To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke

    Timeframe: Up to 42 months

    Time to first event of the composite of: * All-cause death * HHF * MI * Stroke

Sources for outcomes
clinicaltrials.gov

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

  • Left ventricular ejection fraction (LVEF) of > 40% within 12 months prior to screening.
  • Structural heart disease evidence.
  • HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.

  • BMI <25 kg/m² at screening.
  • Diabetes exclusions:
  • History of type 1 diabetes.
  • HbA1c ≥10% at screening.
  • Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
  • more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition.
  • Renal exclusions:
  • On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening
  • Cardiovascular exclusions:
  • Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization.
  • Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia.
  • GI exclusions:
  • Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery.
  • History of acute or chronic pancreatitis.
  • Endocrine exclusions:
  • History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.
Sources for eligibility
clinicaltrials.gov

  • Research SiteFairhope, United StatesRecruiting
  • Research SiteAnchorage, United StatesNot yet recruiting
  • Research SiteGilbert, United StatesNot yet recruiting
  • Research SiteSun City, United StatesNot yet recruiting
  • Research SiteBeverly Hills, United StatesNot yet recruiting
  • Research SiteHuntington Beach, United StatesNot yet recruiting
  • Research SiteHuntington Park, United StatesNot yet recruiting
  • Research SiteLoma Linda, United StatesNot yet recruiting
  • Research SiteLomita, United StatesRecruiting
  • Research SiteMather, United StatesNot yet recruiting
  • Research SiteNorthridge, United StatesNot yet recruiting
  • Research SitePalo Alto, United StatesNot yet recruiting
  • Research SiteRedding, United StatesNot yet recruiting
  • Research SiteSan Diego, United StatesNot yet recruiting
  • Research SiteTarzana, United StatesWithdrawn
  • Research SiteColorado Springs, United StatesNot yet recruiting
  • Research SiteNew Haven, United StatesNot yet recruiting
  • Research SiteBradenton, United StatesWithdrawn
  • Research SiteHallandale, United StatesNot yet recruiting
  • Research SiteJacksonville, United StatesNot yet recruiting
  • Research SiteLakeland, United StatesNot yet recruiting
  • Research SiteMiami, United StatesNot yet recruiting
  • Research SiteMiami, United StatesNot yet recruiting
  • Research SiteMiami, United StatesNot yet recruiting
  • Research SiteMiami Lakes, United StatesWithdrawn

And 654 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-526304-79-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)