Heart Failure, DiastolicPhase 2ACTIVATE-HFpEFNCT07920887
A Study of Bimagrumab in Participants With HFpEF
A Phase 2 study testing Bimagrumab in people with Heart Failure, Diastolic and Diastolic Heart Failure, run by Eli Lilly and Company at 9 sites in 4 countries.
Trial summary
This study will look at how bimagrumab affects adults who have a type of heart failure called HFpEF (heart failure with preserved ejection fraction), where the heart pumps normally but does not fill with blood as well as it should. Participation in the study will last about 76 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic, Diastolic Heart Failure, Heart Failure, Normal Ejection Fraction
- What is being tested?
- Bimagrumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Nov 2026to Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have New York Heart Association Class II to III heart failure
- Have left ventricular ejection fraction (LVEF) ≥ 50%
- KCCQ-CSS ≤ 80
- 6MWD must be all of the following:
- ≥100 and ≤ 450 meters (m) based on average of 2 tests conducted at screening visit, AND
- ≥ 100 and ≤ 450 m on 1 test at randomization visit, AND
Show all 14Show fewer
- < 20% change from average qualifying 6MWD obtained at screening
- Have documented evidence of at least one of the following:
- Heart failure event
- Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide)
- Left atrium enlargement
- Elevated filling pressure
- Stable dose of heart failure medications
- Body mass index (BMI) ≥ 23 kilograms per meter squared (kg/m²)
Who cannot join
- Heart failure hospitalization < 4 weeks before screening
- Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery/intervention, stroke or transient ischemic attack in past 12 weeks prior to screening, or unstable angina pectoris in past 4 weeks prior to screening or during screening
- Type 1 diabetes
- Hemoglobin A1c (HbA1c) ≥ 9.5%
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
9 sites in 4 countries
United States3 sites
Dharma PA d/b/a Southwest Family Medicine Associates
Dallas, Texas, 75235
Chrisette Dharma
Amavita Research Services, LLC
North Miami Beach, Florida, 33169
Pedro Martinez-Clark
InvivoCure LLC
Van Nuys, California, 91405
Rodney Samaan
Poland3 sites
Krakowski Szpital Specjalistyczny im. sw. Jana Pawla II
Krakow, 31-202
Pawel Rubis
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-556
Joanna Szachniewicz
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
Wroclaw, 50-981
Bartosz Krakowiak
Italy2 sites
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Sant' Anna e San Sebastiano di Caserta
Caserta, 81100
0823 23207475
Paolo Calabro
A.O. Ordine Mauriziano di Torino
Torino, 10128
Giuseppe Musumeci
Hungary1 site
Semmelweis Egyetem - Varosmajori Sziv es Ergyogyaszati Klinika
Budapest, H-1122
Bela Merkely
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Comparing the Efficacy and Safety of Bimagrumab Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction (ACTIVATE-HFpEF)
This study will look at how bimagrumab affects adults who have a type of heart failure called HFpEF (heart failure with preserved ejection fraction), where the heart pumps normally but does not fill with blood as well as it should. Participation in the study will last about 76 weeks.
- Conditions
- Heart Failure, Diastolic, Diastolic Heart Failure, Heart Failure, Normal Ejection Fraction, Heart Failure, Preserved Ejection Fraction
- Being tested
- Bimagrumab, Placebo
- Keywords
- Muscle, Sarcopenia, Physical function, Adipose tissue
- Medical subject headings
- Heart Failure, Diastolic, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimagrumabDrug
Also called LY3985863
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Bimagrumab Dose 1 | Experimental | Participants will receive bimagrumab subcutaneously (SC) Receives: Drug: Bimagrumab |
| Bimagrumab Dose 2 | Experimental | Participants will receive bimagrumab SC Receives: Drug: Bimagrumab |
| Placebo 1 | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
| Placebo 2 | Placebo comparator | Participants will receive placebo SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS)
Measured: Baseline, Week 52
Secondary outcomes (6)
Change from Baseline in the 6-Minute Walk Test Distance (6MWD)
Measured: Baseline, Week 52
Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Measured: Baseline, Week 52
Percentage of Participants who Achieve Responder Status for KCCQ-CSS
Measured: Week 52
Percentage of Participants who Achieve Responder Status for 6-Minute Walk Test Distance
Measured: Week 52
Change from Baseline in Early Transmitral Inflow Velocity / Early Diastolic Mitral Annular Velocity (E/e')
Measured: Baseline, Week 52
Change from Baseline in Total Body Lean Mass
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920887
- Sponsor's protocol ID
- 27879
- Other IDs
- J4Z-MC-GIDK, 2026-527983-34-00
- Acronym
- ACTIVATE-HFpEF
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Comparing the Efficacy and Safety of Bimagrumab Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction (ACTIVATE-HFpEF)
- ClinicalTrials.gov ID
- NCT07920887
- Acronym / sponsor ID
- ACTIVATE-HFpEF / 27879
- Conditions
- Heart Failure, Diastolic, Diastolic Heart Failure, Heart Failure, Normal Ejection Fraction, Heart Failure, Preserved Ejection Fraction
- Keywords
- Muscle, Sarcopenia, Physical function, Adipose tissue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how bimagrumab affects adults who have a type of heart failure called HFpEF (heart failure with preserved ejection fraction), where the heart pumps normally but does not fill with blood as well as it should. Participation in the study will last about 76 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bimagrumab Dose 1 | Experimental | Drug: BimagrumabParticipants will receive bimagrumab subcutaneously (SC) |
| Bimagrumab Dose 2 | Experimental | Drug: BimagrumabParticipants will receive bimagrumab SC |
| Placebo 1 | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC |
| Placebo 2 | Placebo comparator | Drug: PlaceboParticipants will receive placebo SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have New York Heart Association Class II to III heart failure
- Have left ventricular ejection fraction (LVEF) ≥ 50%
- KCCQ-CSS ≤ 80
- 6MWD must be all of the following:
- Have documented evidence of at least one of the following:
Key exclusion criteria (4 listed)
- Heart failure hospitalization < 4 weeks before screening
- Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery/intervention, stroke or transient ischemic attack in past 12 weeks prior to screening, or unstable angina pectoris in past 4 weeks prior to screening or during screening
- Type 1 diabetes
- Hemoglobin A1c (HbA1c) ≥ 9.5%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimagrumabAlso: LY3985863Administered SC | Drug | Bimagrumab Dose 1, Bimagrumab Dose 2 |
| PlaceboAdministered SC | Drug | Placebo 1, Placebo 2 |
Primary outcome
Change from Baseline in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS)
Time frame: Baseline, Week 52
6 secondary outcomes
Change from Baseline in the 6-Minute Walk Test Distance (6MWD)
Time frame: Baseline, Week 52
Change from baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline, Week 52
Percentage of Participants who Achieve Responder Status for KCCQ-CSS
Time frame: Week 52
Percentage of Participants who Achieve Responder Status for 6-Minute Walk Test Distance
Time frame: Week 52
Change from Baseline in Early Transmitral Inflow Velocity / Early Diastolic Mitral Annular Velocity (E/e')
Time frame: Baseline, Week 52
Change from Baseline in Total Body Lean Mass
Time frame: Baseline, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bimagrumab in people with Heart Failure, Diastolic and Diastolic Heart Failure, run by Eli Lilly and Company at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Poland, Italy, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.