5610 Participants NeededMy employer runs this trial

NNC0487-0111 for Obesity and Heart Failure

(HF-POLARIS Trial)

Recruiting at 901 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new medicine, NNC0487-0111, for individuals with certain types of heart failure and excess body weight. The study compares the effects of NNC0487-0111 to a placebo, administered by injection once a week. Participants are randomly assigned to receive either the new medicine or the placebo. The trial seeks individuals diagnosed with heart failure and a Body Mass Index (BMI) of 30 or higher, indicating excess body weight. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that NNC0487-0111 is likely to be safe for humans?

Research has shown that NNC0487-0111, also known as Amycretin, is generally safe for people. Studies have found it well-tolerated by individuals who are overweight or have obesity, with no new safety concerns reported. Participants took the treatment once a week, which most found manageable. While ongoing studies continue to monitor its safety, the results so far are promising. This treatment works by activating certain proteins in the body to help control weight. Overall, current evidence indicates that the treatment appears safe and well-tolerated.12345

Why do researchers think this study treatment might be promising?

NNC0487-0111 is unique because it targets both obesity and heart failure, making it a promising dual-purpose treatment. Unlike standard treatments that typically focus on either managing weight or improving heart function separately, this drug offers a combined approach. It is administered subcutaneously in a dose-escalating manner, which could provide more controlled and potentially more effective results. Researchers are particularly excited about its ability to address these two interconnected conditions simultaneously, which could lead to better overall patient outcomes.

What evidence suggests that NNC0487-0111 might be an effective treatment for heart failure with excess body weight?

Research has shown that NNC0487-0111, a new treatment tested in this trial, might help with obesity and heart failure. Earlier studies found that it can lead to weight loss, with some individuals losing up to 22% of their body weight. This treatment combines two hormones, GLP-1 and amylin, which work together to control hunger and enhance the body's energy use. Early results suggest it could be promising for heart failure by potentially improving heart function and reducing obesity-related issues. Although more research is needed, these initial findings are encouraging. Participants in this trial will receive either NNC0487-0111 or a placebo.16789

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults with heart failure (with preserved or mildly reduced ejection fraction) who are also obese (BMI of 30 or higher). Participants must be in stable condition. People with type 1 diabetes, certain eye problems, recent serious heart events, severe lung disease, or other specific heart conditions cannot join.

Inclusion Criteria

Body Mass Index (BMI) greater than or equal to (">=") 30 kilograms per square metre (kg/m^2) at screening.
I have heart failure (NYHA class II-IV) and my condition is stable.
I was diagnosed with Type 2 Diabetes at least 30 days ago.

Exclusion Criteria

History of type 1 diabetes.
Glycated haemoglobin (HbA1c) greater than (">") 10 percent (%) (86 [millimoles per mole] mmol/mol) as measured by local or central laboratory at screening.
My heart failure is not caused by rare heart muscle or valve diseases.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NNC0487-0111 or placebo by injection once a week

165 weeks
Weekly injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NNC0487-0111

Trial Overview

The study compares a new medicine called NNC0487-0111 to a placebo in people with both obesity and certain types of heart failure. Participants get weekly injections chosen at random to see if the new drug is safe and works better than no active treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NNC0487-0111Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

A Research Study to Look at How Well NNC0487-0111 ...

This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction ...

Amycretin, a novel, unimolecular GLP-1 and amylin ...

Recent phase 1 clinical trial data have reported that oral amycretin appeared safe and tolerable (most treatment-emergent adverse events were ...

Combos, CagriSema, and Heart Failure - GLP-1 Observer

NEWLY REGISTERED TRIALS (10 in last week). NNC0487-0111 Phase 3 trial evaluating efficacy in people with heart failure and obesity (Novo ...

A Research Study to Look at How Well NNC0487-0111 Works ...

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 ...

The effect of amycretin, a unimolecular glucagon-like peptide ...

This study aimed to determine its role in mitigating diet-induced metabolic disorders, such as obesity, insulin resistance, and fatty liver ...

NNC0487-0111 for Obesity · Info for Participants

In summary, current data suggest that NNC0487-0111 is safe for humans based on previous research. However, ongoing studies will continue to monitor its safety ...

Dahl_EASD25_s_c_amycretin_o...

Amycretin (NNC0487-0111) is a unimolecular GLP-1 and amylin ... and tolerable in people with overweight or obesity,1 with no new safety signals ...

Supplementary appendix

doses of NNC0487-0111 in participants with overweight or obesity. Objectives and endpoints: Part A. Primary objective and endpoint ...

A Research Study Looking at How NNC0487-0111 Affects ...

The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when ...