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NCT07567001·Phase 3·INTERVENTIONAL

A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity

Status

Recruiting

Phase

Phase 3

Enrollment

5,610

Locations

839

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.

Interventions

Treatment arms and agents.

DRUG

NNC0487-0111

NNC0487-011 will be administered subcutaneously.

DRUG

Placebo

Placebo (matched to NNC0487-011) will be administered subcutaneously.

Timeline

From registration to results.

  1. First posted

    May 5, 2026

  2. Study start

    May 11, 2026

  3. Primary completion

    Jul 23, 2029

  4. Study completion

    Aug 15, 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jul 15, 2026

Outcomes

What the study measures.

Primary outcomes

Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death

Time frame · From baseline (week 0) to 165 weeks

Measured in days.

Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit

Time frame · From baseline (week 0) to 165 weeks

Measured in days.

Secondary outcomes

Time to first occurrence of a composite HF and Major Adverse Cardiovascular Events (MACE) end-point consisting of: CV death, HF hospitalisation or urgent HF visit, Nonfatal Myocardial Infraction (MI), Nonfatal stroke

Time frame · From baseline (week 0) to 165 weeks

Measured in days.

Change in Clinical Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-CSS) for participants with baseline KCCQ-CSS score less than (<) 80 points

Time frame · From baseline (week 0) to week 52

Measured as score on scale. KCCQ measures Health-Related Quality of Life (HRQOL). Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms and greater disease-specific HRQoL.

Change in estimated Glomerular Filtration Rate (eGFR) (creatinine and cystatin C-based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021) for participants with baseline eGFR< 60 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2)

Time frame · From baseline (week 0) to week 78

Measured as mL/min/1.73 m\^2.

Time to all-cause death

Time frame · From baseline (week 0) to 165 weeks

Measured in days.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Body Mass Index (BMI) greater than or equal to (\>=) 30 kilograms per square metre (kg/m\^2) at screening. * Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator. For participants with Type 2 Diabetes (T2D) at screening: \- Diagnosed with T2D \>= 30 days before screening. Exclusion Criteria: * MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization. * HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree. * Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as: * requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening. * Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism). Glycaemia-related: * History of type 1 diabetes. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Glycated haemoglobin (HbA1c) greater than (\>) 10 percent (%) (86 \[millimoles per mole\] mmol/mol) as measured by local or central laboratory at screening.

Study locations

839 registered sites.

Argentina · Australia · Brazil · Bulgaria · Canada · China · Czechia · Denmark · France · Germany · Greece · India · Israel · Italy · Japan · Malaysia · Mexico · Netherlands · Poland · Puerto Rico · South Africa · South Korea · Spain · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Advanced Cardiovascular, LLC

Alexander City, Alabama, United States

Univ of Alabama Birmingham

Birmingham, Alabama, United States

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, United States

Mobile Heart USA Health Cardiology Clinic

Mobile, Alabama, United States

Mercy Gilbert Medical Center

Gilbert, Arizona, United States

Sun City Clinical Research

Glendale, Arizona, United States

Honor Health

Phoenix, Arizona, United States

Arizona Research Center

Phoenix, Arizona, United States

Arkansas Health Group

Little Rock, Arkansas, United States

InvivoCure -2

Alhambra, California, United States

Cardio Research of S. Cal

Beverly Hills, California, United States

Westside Medical Associates Los Angeles

Beverly Hills, California, United States

Scripps Hospital

Chula Vista, California, United States

John Muir Physicians Network

Concord, California, United States

Valley Clinical Trials

Covina, California, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Amicis Research Center

Granada Hills, California, United States

California Heart Specialist

Huntington Beach, California, United States

Valiance Clinical Research

Huntington Park, California, United States

Joe C.Wen & Fam CTR for Adv Care

Irvine, California, United States

Scripps Memorial Hospital La Jolla

La Jolla, California, United States

UCSD NAFLD Research Center

La Jolla, California, United States

Cardio Innovation & Resch Ctr

Long Beach, California, United States

Pacific Clinical Studies

Los Alamitos, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.