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Clinical Trials in India / NCT07567001
Recruiting Phase 3

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

NCT07567001 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2026-05-11
Last updated
2026-08-18

Condition(s) studied

ObesityHeart Failure

Investigational drug(s) / intervention(s)

NNC0487-0111Placebo

NNC0487-0111: NNC0487-011 will be administered subcutaneously.

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (838)

FacilityCityRegionStatus
Advanced Cardiovascular, LLC Alexander City Alabama Recruiting
Univ of Alabama Birmingham Birmingham Alabama Not Yet Recruiting
Eastern Shore Rsrch Inst, LLC Fairhope Alabama Recruiting
Mobile Heart USA Health Cardiology Clinic Mobile Alabama Not Yet Recruiting
Mercy Gilbert Medical Center Gilbert Arizona Recruiting
Sun City Clinical Research Glendale Arizona Recruiting
Honor Health Phoenix Arizona Not Yet Recruiting
Arizona Research Center Phoenix Arizona Not Yet Recruiting
Arkansas Health Group Little Rock Arkansas Not Yet Recruiting
InvivoCure -2 Alhambra California Recruiting
Cardio Research of S. Cal Beverly Hills California Recruiting
Westside Medical Associates Los Angeles Beverly Hills California Recruiting
Scripps Hospital Chula Vista California Recruiting
John Muir Physicians Network Concord California Recruiting
Valley Clinical Trials Covina California Recruiting
Mission Cardiovascular Research Institute Fremont California Recruiting
Amicis Research Center Granada Hills California Recruiting
California Heart Specialist Huntington Beach California Recruiting
Valiance Clinical Research Huntington Park California Recruiting
Joe C.Wen & Fam CTR for Adv Care Irvine California Not Yet Recruiting
Scripps Memorial Hospital La Jolla La Jolla California Not Yet Recruiting
UCSD NAFLD Research Center La Jolla California Not Yet Recruiting
Cardio Innovation & Resch Ctr Long Beach California Recruiting
Pacific Clinical Studies Los Alamitos California Recruiting
VAGrtrLosAngelesHlthcareSystem Los Angeles California Not Yet Recruiting
Amicis Research Center Northridge California Recruiting
JPJ Research Northridge California Recruiting
Valley Clinical Trials Northridge California Recruiting
Desert Oasis Healthcare Palm Springs California Recruiting
Empire Clin. Research Pomona California Not Yet Recruiting
G&J Research San Diego California Recruiting
San Diego Veterans Affairs San Diego California Recruiting
Kaiser Permanente Northern California San Francisco California Not Yet Recruiting
San Francisco V.A. Medical Center San Francisco California Not Yet Recruiting
Fomat Medical Research Santa Maria California Recruiting
NorthBay Clinical Research Santa Rosa California Recruiting
St. Joseph's Medical Center Stockton California Not Yet Recruiting
Valiance Clinical Research Tarzana California Recruiting
Care Access Research Thousand Oaks California Recruiting
InvivoCure Van Nuys California Recruiting

+ 798 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07567001 on ClinicalTrials.gov ↗ ← All trials in India