Recruiting
Phase 3

NNC0487-0111

Sponsor:

Novo Nordisk A/S

Code:

NCT07567001

Conditions

Obesity

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0487-0111

Placebo

Study Details

Brief 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.

Conditions

Obesity

Heart Failure

Study ID

NCT07567001

Start date

May 11, 2026

Status verified date

Aug, 2026

Completion date

Aug 15, 2029

Anticipated

Primary completion date

Jul 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5610 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC0487-0111

Participants will receive NNC0487-0111 subcutaneously (s.c.) in a dose escalating manner once weekly.

placebo comparator: Placebo

Participants will receive placebo matched to NNC0487-011 s.c. once weekly.

Interventions

NNC0487-0111

NNC0487-011 will be administered subcutaneously.

Placebo

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

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Advanced Cardiovascular, LLC

Recruiting

Alexander City, Alabama, United States, 35010

Eastern Shore Rsrch Inst, LLC

Recruiting

Fairhope, Alabama, United States, 36532

Mercy Gilbert Medical Center

Recruiting

Gilbert, Arizona, United States, 85297

Sun City Clinical Research

Recruiting

Glendale, Arizona, United States, 85304

InvivoCure -2

Recruiting

Alhambra, California, United States, 91801

Cardio Research of S. Cal

Recruiting

Beverly Hills, California, United States, 90210

Westside Medical Associates Los Angeles

Recruiting

Beverly Hills, California, United States, 90211

Scripps Hospital

Recruiting

Chula Vista, California, United States, 91910

John Muir Physicians Network

Recruiting

Concord, California, United States, 94520

Valley Clinical Trials

Recruiting

Covina, California, United States, 91723

Mission Cardiovascular Research Institute

Recruiting

Fremont, California, United States, 94538

Amicis Research Center

Recruiting

Granada Hills, California, United States, 91344

California Heart Specialist

Recruiting

Huntington Beach, California, United States, 92648-1717

Valiance Clinical Research

Recruiting

Huntington Park, California, United States, 90255

Cardio Innovation & Resch Ctr

Recruiting

Long Beach, California, United States, 90813

Pacific Clinical Studies

Recruiting

Los Alamitos, California, United States, 90720

Amicis Research Center

Recruiting

Northridge, California, United States, 91324

JPJ Research

Recruiting

Northridge, California, United States, 91324

Valley Clinical Trials

Recruiting

Northridge, California, United States, 91325

Desert Oasis Healthcare

Recruiting

Palm Springs, California, United States, 92262

G&J Research

Recruiting

San Diego, California, United States, 92117

San Diego Veterans Affairs

Recruiting

San Diego, California, United States, 92161

Fomat Medical Research

Recruiting

Santa Maria, California, United States, 93454

NorthBay Clinical Research

Recruiting

Santa Rosa, California, United States, 95405

Valiance Clinical Research

Recruiting

Tarzana, California, United States, 91356

Care Access Research

Recruiting

Thousand Oaks, California, United States, 91360

InvivoCure

Recruiting

Van Nuys, California, United States, 91405

Blue Coast Research Center

Recruiting

Vista, California, United States, 92081

Interventional Cardiology Medical Group

Recruiting

West Hills, California, United States, 91307

Univ of Colorado at Denver

Recruiting

Aurora, Colorado, United States, 80045

Colorado Heart and Vascular PC

Recruiting

Golden, Colorado, United States, 80401

BayCare Health System

Recruiting

Clearwater, Florida, United States, 33756

Broward Research Ctr.

Recruiting

Coral Gables, Florida, United States, 33134

Nature Coast Clinical Research

Recruiting

Crystal River, Florida, United States, 34429

Arrow Clinical Trials

Recruiting

Daytona Beach, Florida, United States, 32117

Inpatient Research Clinic LLC

Recruiting

Florida City, Florida, United States, 33034

Jacksonville Ctr for Clin Res

Recruiting

Jacksonville, Florida, United States, 32216

K2 Medical Research

Recruiting

Maitland, Florida, United States, 32751

Total Research Group LLC

Recruiting

Miami, Florida, United States, 33126

Infinite Clinical Research

Recruiting

Miami, Florida, United States, 33133-4223

Future Life Clinical Trials

Recruiting

Miami, Florida, United States, 33169

Broward Research Ctr.

Recruiting

Miami Beach, Florida, United States, 33140

Inpatient Research Clinic LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Suncoast Clinical Research, Inc.

Recruiting

New Port Richey, Florida, United States, 34652

Ocala Cardiovascular Research

Recruiting

Ocala, Florida, United States, 34471

Cardiovascular Institute of Orlando

Recruiting

Orlando, Florida, United States, 32807

Ormond Beach Clinical Research

Recruiting

Ormond Beach, Florida, United States, 32174

DBC Research - Pembroke Pines

Recruiting

Pembroke Pines, Florida, United States, 33029-1406

SEC Clinical Research

Recruiting

Pensacola, Florida, United States, 32503

Clearwater Cardiovascular Consultants

Recruiting

Safety Harbor, Florida, United States, 34695

St Joseph's Hospital Foundation

Recruiting

Tampa, Florida, United States, 33607

Tampa Cardiovascular Interventions and Research

Recruiting

Tampa, Florida, United States, 33614

Hope Research Network

Recruiting

Virginia Gardens, Florida, United States, 33166

Guardian Research Org LLC

Recruiting

Winter Park, Florida, United States, 32792

American Clinical Trials, LLC

Recruiting

Acworth, Georgia, United States, 30101

Atlanta Center for Clinical Research_Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

East Atlanta Cardiology

Recruiting

Conyers, Georgia, United States, 30012

Hope Clin Res & Wellness

Recruiting

Conyers, Georgia, United States, 30094

Northeast Georgia Medical Ctr

Recruiting

Gainesville, Georgia, United States, 30501

NSC Research, Inc

Recruiting

Johns Creek, Georgia, United States, 30024

Peachtree Cardiology

Recruiting

Peachtree, Georgia, United States, 30269

Cardiovascular Consultants of South Georgia

Recruiting

Thomasville, Georgia, United States, 31792

Atlanta Heart Specialists, LLC

Recruiting

Tucker, Georgia, United States, 30084

Chicago Clinical Research Institute INC

Recruiting

Chicago, Illinois, United States, 60607

Eagle Clinical Research

Recruiting

Chicago, Illinois, United States, 60621

Chicago Medical Research LLC

Recruiting

Hazel Crest, Illinois, United States, 60429

Chicago Clinical Research Institute INC

Recruiting

Orland Park, Illinois, United States, 60462

Methodist Medical Center of Illinois

Recruiting

Peoria, Illinois, United States, 61603

Asha Clinical Rsch-Munster, LLC

Recruiting

Hammond, Indiana, United States, 46324

Indiana University Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

The Research Group of Lexington LLC

Recruiting

Lexington, Kentucky, United States, 40503

Research Integrity Global, LLC

Recruiting

Owensboro, Kentucky, United States, 42303

Grace Research, LLC

Recruiting

Bossier City, Louisiana, United States, 71111

Horizon Research Group of Opelousas, LLC

Recruiting

Eunice, Louisiana, United States, 70535

Cardiovascular Institute of the South

Recruiting

Houma, Louisiana, United States, 70360-4413

Cardiovascular Institute of the South

Recruiting

Opelousas, Louisiana, United States, 70570

Flourish Research Bowie

Recruiting

Bowie, Maryland, United States, 20715

Anderson Medical Group

Recruiting

Ft. Washington, Maryland, United States, 20744

Adventist HealthCare Shady Grove Medical Center

Recruiting

Rockville, Maryland, United States, 20850

Cardio and Vascular Assoc-CAVA

Recruiting

Bloomfield Hills, Michigan, United States, 48304

University Of Michigan

Recruiting

Lansing, Michigan, United States, 48912

Henry Ford Health System

Recruiting

Southfield, Michigan, United States, 48075

Trinity Health Michigan Heart

Recruiting

Ypsilanti, Michigan, United States, 48197

Clinical Research Consultants, JCCT Co

Recruiting

Kansas City, Missouri, United States, 64111

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Amicis Centers of Clinical Research

Recruiting

St Louis, Missouri, United States, 63128

Velocity Clinical Research Lincoln

Recruiting

Lincoln, Nebraska, United States, 68510

Palm Research Center Inc-Vegas

Recruiting

Las Vegas, Nevada, United States, 89128

Heart House - Sewell

Recruiting

Sewell, New Jersey, United States, 08080

Cardio Metabolic Institute

Recruiting

Somerset, New Jersey, United States, 08873

Capital Cardiology Associates_Albany

Recruiting

Albany, New York, United States, 12211

Clindove Research

Recruiting

Brooklyn, New York, United States, 11201

Peak Clinical Trials

Recruiting

Apex, North Carolina, United States, 27502

Hawthorne Health NC

Recruiting

Concord, North Carolina, United States, 28025

IMA Research

Recruiting

Lenoir, North Carolina, United States, 28645

PHC Accelacare

Recruiting

Statesville, North Carolina, United States, 28625

Providence Health Partners Ctr

Recruiting

Dayton, Ohio, United States, 45439

K&R Research Llc

Recruiting

Marion, Ohio, United States, 43302

Advanced Medical Research

Recruiting

Maumee, Ohio, United States, 43537

STAT Research Ohio

Recruiting

Vandalia, Ohio, United States, 45377

Penn Med. Lancaster Gen Hospital

Recruiting

Lancaster, Pennsylvania, United States, 17603

Med. Uni. of SC Ashley River T

Recruiting

Charleston, South Carolina, United States, 29425

Piedmont Research Partners, LLC

Recruiting

Fort Mill, South Carolina, United States, 29707

Balad Hlth Sys-Welmont CardCVA

Recruiting

Greeneville, Tennessee, United States, 37745

The Jackson Clinic, PA

Recruiting

Jackson, Tennessee, United States, 38305

PharmaTex Research, LLC

Recruiting

Amarillo, Texas, United States, 79106

Javara Inc. / Privia Medical Group Gulf Coast PLLC

Recruiting

Conroe, Texas, United States, 77384

South Texas Clinical Research

Recruiting

Corpus Christi, Texas, United States, 78404

Renal Disease Research Institute

Recruiting

Dallas, Texas, United States, 75204

Southwest Family Medicine_Dallas

Recruiting

Dallas, Texas, United States, 75235

UTD SW Medical Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Texama Medical Center

Recruiting

Denison, Texas, United States, 75020

Dallas Heart and Vascular

Recruiting

Duncanville, Texas, United States, 75137

Proactive El Paso LLC

Recruiting

El Paso, Texas, United States, 79902

David Turbay, MD, PLLC

Recruiting

El Paso, Texas, United States, 79905

Care United Research, LLC

Recruiting

Forney, Texas, United States, 75126

East Texas Cardiology PA

Recruiting

Houston, Texas, United States, 77002

Victorium Clinical Research

Recruiting

Houston, Texas, United States, 77024

Main Heart Clinic

Recruiting

Houston, Texas, United States, 77025

Card Specialists of Willowbrook

Recruiting

Houston, Texas, United States, 77070

Biopharma Informatic, LLC

Recruiting

McAllen, Texas, United States, 78503

North Texas Research Associates

Recruiting

McKinney, Texas, United States, 75071

University Hospital

Recruiting

San Antonio, Texas, United States, 78229

Sherman Clinical Research

Recruiting

Sherman, Texas, United States, 75090

Medrasa Clinical Research

Recruiting

Sherman, Texas, United States, 75092

TPMG Clinical Research

Recruiting

Newport News, Virginia, United States, 23606

Sentara Health Research Center

Recruiting

Norfolk, Virginia, United States, 23507

Conquest Research

Recruiting

Vienna, Virginia, United States, 22182

Selma Medical Associates

Recruiting

Winchester, Virginia, United States, 22601-3834

Cardio Research & Education Foundation

Recruiting

Wausau, Wisconsin, United States, 54401

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4Z6

G.A. Research Associates Ltd.

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Curnew Medicine Professional Corporation

Recruiting

Hamilton, Ontario, Canada, L8L 0A9

Cardio Health Clinical Trials

Recruiting

Hamilton, Ontario, Canada, L8W 3K5

North York Diagn & Cardiac Ctr

Recruiting

North York, Ontario, Canada, M6B 3H7

Diabetes Heart Research Centre

Recruiting

Toronto, Ontario, Canada, M6G 1M2

CPS Research

Recruiting

Waterloo, Ontario, Canada, N2T 0C1

Winchester Dist Memorial Hosp

Recruiting

Winchester, Ontario, Canada, K0C 2K0

CIUSSS du Saguenay-Lac-St-Jean

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

Diex Recherche Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1E 0N8

Diex Recherche Trois-Rivieres

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

CHU de Quebec-Uni Laval-Hotel

Recruiting

Québec, Canada, G1R2J6

IUCPQ - Universite Laval

Recruiting

Québec, Canada, G1V 4G5

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-08-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.