> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-cv-outcomes-with-elecoglipron-3d08a91b-ae7a-4bb4-a99c-b257d1bd8980 > Record changed: 2026-11-04 # A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF NCT07761117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) Participants 6,950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) Start date 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) Number of sites 679 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Acronym** Elevate-HF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Short title** A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Dates **Completion date** 2029-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **First posted** 2026-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Registry last updated** 2026-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Primary completion date** 2029-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Start date** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Size and sites **Participants** 6,950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Planned participants** 6,950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Number of sites** 679 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Identifiers **Registry ID** NCT07761117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **ClinicalTrials.gov ID** NCT07761117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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. ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## References ### Other registry identifiers - 2026-526304-79-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07761117) ## Related records ### Drugs (1) - [Elecoglipron](https://trialight.com/data/asset/elecoglipron-8e9246dc-f27c-5602-b7aa-f57855d22924.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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