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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NNC0487-0111 		Participants will receive NNC0487-0111 subcutaneously (s.c.) in a dose escalating manner once weekly.
  • Drug: NNC0487-0111
    NNC0487-011 will be administered subcutaneously.
Placebo Comparator
Placebo 		Participants will receive placebo matched to NNC0487-011 s.c. once weekly.
  • Drug: Placebo
    Placebo will be administered subcutaneously.

Recruiting Locations

Advanced Cardiovascular, LLC
Alexander City, Alabama 35010

Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama 36532

Sun City Clinical Research
Glendale, Arizona 85304

InvivoCure -2
Alhambra, California 91801

Cardio Research of S. Cal
Beverly Hills, California 90210

Westside Medical Associates Los Angeles
Beverly Hills, California 90211

Scripps Hospital
Chula Vista, California 91910

Valley Clinical Trials
Covina, California 91723

Mission Cardiovascular Research Institute
Fremont, California 94538

Amicis Research Center
Granada Hills, California 91344

California Heart Specialist
Huntington Beach, California 92648-1717

Valiance Clinical Research
Huntington Park, California 90255

Cardio Innovation & Resch Ctr
Long Beach, California 90813

Pacific Clinical Studies
Los Alamitos, California 90720

Amicis Research Center
Northridge, California 91324

JPJ Research
Northridge, California 91324

Valley Clinical Trials
Northridge, California 91325

Desert Oasis Healthcare
Palm Springs, California 92262

G&J Research
San Diego, California 92117

Fomat Medical Research
Santa Maria, California 93454

NorthBay Clinical Research
Santa Rosa, California 95405

Valiance Clinical Research
Tarzana, California 91356

Care Access Research
Thousand Oaks, California 91360

InvivoCure
Van Nuys, California 91405

Blue Coast Research Center
Vista, California 92081

Interventional Cardiology Medical Group
West Hills, California 91307

Univ of Colorado at Denver
Aurora, Colorado 80045

Broward Research Ctr.
Coral Gables, Florida 33134

Nature Coast Clinical Research
Crystal River, Florida 34429

Arrow Clinical Trials
Daytona Beach, Florida 32117

Inpatient Research Clinic LLC
Florida City, Florida 33034

Jacksonville Ctr for Clin Res
Jacksonville, Florida 32216

K2 Medical Research
Maitland, Florida 32751

Infinite Clinical Research
Miami, Florida 33133-4223

Future Life Clinical Trials
Miami, Florida 33169

Broward Research Ctr.
Miami Beach, Florida 33140

Inpatient Research Clinic LLC
Miami Lakes, Florida 33014

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652

Ocala Cardiovascular Research
Ocala, Florida 34471

Cardiovascular Institute of Orlando
Orlando, Florida 32807

Ormond Beach Clinical Research
Ormond Beach, Florida 32174

DBC Research - Pembroke Pines
Pembroke Pines, Florida 33029-1406

SEC Clinical Research
Pensacola, Florida 32503

Clearwater Cardiovascular Consultants
Safety Harbor, Florida 34695

Tampa Cardiovascular Interventions and Research
Tampa, Florida 33614

Hope Research Network
Virginia Gardens, Florida 33166

Guardian Research Org LLC
Winter Park, Florida 32792

American Clinical Trials, LLC
Acworth, Georgia 30101

Atlanta Center for Clinical Research_Atlanta
Atlanta, Georgia 30342

East Atlanta Cardiology
Conyers, Georgia 30012

Hope Clin Res & Wellness
Conyers, Georgia 30094

NSC Research, Inc
Johns Creek, Georgia 30024

Peachtree Cardiology
Peachtree, Georgia 30269

Cardiovascular Consultants of South Georgia
Thomasville, Georgia 31792

Atlanta Heart Specialists, LLC
Tucker, Georgia 30084

Chicago Clinical Research Institute INC
Chicago, Illinois 60607

Eagle Clinical Research
Chicago, Illinois 60621

Chicago Medical Research LLC
Hazel Crest, Illinois 60429

Chicago Clinical Research Institute INC
Orland Park, Illinois 60462

Asha Clinical Rsch-Munster, LLC
Hammond, Indiana 46324

The Research Group of Lexington LLC
Lexington, Kentucky 40503

Research Integrity Global, LLC
Owensboro, Kentucky 42303

Grace Research, LLC
Bossier City, Louisiana 71111

Horizon Research Group of Opelousas, LLC
Eunice, Louisiana 70535

Cardiovascular Institute of the South
Opelousas, Louisiana 70570

Flourish Research Bowie
Bowie, Maryland 20715

Anderson Medical Group
Ft. Washington, Maryland 20744

Adventist HealthCare Shady Grove Medical Center
Rockville, Maryland 20850

Cardio and Vascular Assoc-CAVA
Bloomfield Hills, Michigan 48304

Trinity Health Michigan Heart
Ypsilanti, Michigan 48197

Clinical Research Consultants, JCCT Co
Kansas City, Missouri 64111

Washington University
St Louis, Missouri 63110

Amicis Centers of Clinical Research
St Louis, Missouri 63128

Velocity Clinical Research Lincoln
Lincoln, Nebraska 68510

Palm Research Center Inc-Vegas
Las Vegas, Nevada 89128

Heart House - Sewell
Sewell, New Jersey 08080

Cardio Metabolic Institute
Somerset, New Jersey 08873

Capital Cardiology Associates_Albany
Albany, New York 12211

Clindove Research
Brooklyn, New York 11201

Peak Clinical Trials
Apex, North Carolina 27502

Hawthorne Health NC
Concord, North Carolina 28025

IMA Research
Lenoir, North Carolina 28645

PHC Accelacare
Statesville, North Carolina 28625

Providence Health Partners Ctr
Dayton, Ohio 45439

K&R Research Llc
Marion, Ohio 43302

Advanced Medical Research
Maumee, Ohio 43537

STAT Research Ohio
Vandalia, Ohio 45377

Penn Med. Lancaster Gen Hospital
Lancaster, Pennsylvania 17603

Balad Hlth Sys-Welmont CardCVA
Greeneville, Tennessee 37745

PharmaTex Research, LLC
Amarillo, Texas 79106

Javara Inc. / Privia Medical Group Gulf Coast PLLC
Conroe, Texas 77384

Renal Disease Research Institute
Dallas, Texas 75204

Southwest Family Medicine_Dallas
Dallas, Texas 75235

UTD SW Medical Center-Dallas
Dallas, Texas 75390

Texama Medical Center
Denison, Texas 75020

Dallas Heart and Vascular
Duncanville, Texas 75137

Proactive El Paso LLC
El Paso, Texas 79902

David Turbay, MD, PLLC
El Paso, Texas 79905

Care United Research, LLC
Forney, Texas 75126

East Texas Cardiology PA
Houston, Texas 77002

Victorium Clinical Research
Houston, Texas 77024

Main Heart Clinic
Houston, Texas 77025

Card Specialists of Willowbrook
Houston, Texas 77070

Biopharma Informatic, LLC
McAllen, Texas 78503

North Texas Research Associates
McKinney, Texas 75071

University Hospital
San Antonio, Texas 78229

Medrasa Clinical Research
Sherman, Texas 75092

TPMG Clinical Research
Newport News, Virginia 23606

Conquest Research
Vienna, Virginia 22182

Selma Medical Associates
Winchester, Virginia 22601-3834

Torre De Plaza Las Americas
San Juan, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

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