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Official title A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity
ClinicalTrials.gov ID: NCT07567001
What this study is testing
What is NNC0487-0111?
NNC0487-0111 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day...
- HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas...
- Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD)...
- 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.
See the full eligibility 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...
- 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...
- 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...
- Glycated haemoglobin (HbA1c) greater than (\>) 10 percent (%) (86 [millimoles per mole] mmol/mol) as measured by local or central laboratory at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Alexander City, Alabama, United States
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Mobile, Alabama, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Alhambra, California, United States
- Beverly Hills, California, United States
- Chula Vista, California, United States
- Concord, California, United States
- Covina, California, United States
- Fremont, California, United States
- Granada Hills, California, United States
- Huntington Beach, California, United States
- Huntington Park, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
+ 653 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexander City, Alabama, United States; Birmingham, Alabama, United States; Fairhope, Alabama, United States; Mobile, Alabama, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States and 667 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.