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

Plain-language guide to NCT07567001: phase 3 randomized trial of Amycretin, 5610 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07567001
Phase
phase 3
Status
recruiting participants
Start
2026-05-11
Completion (planned or actual)
2029-07-23
Participants
5610 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Obesity; Heart Failure
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Amycretin.

Participants will get NNC0487-0111 or placebo by injection once a week.

It had two arms (groups): NNC0487-0111 (experimental) and Placebo (placebo comparator).

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 5610 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: 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).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Amycretin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Amycretin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-05-11 with completion listed for 2029-07-23.

It ran at 838 sites in United States (206), Germany (46), Poland (46), India (45), United Kingdom (37) and Bulgaria (34).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Amycretin in 5610 people.

With 5610 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amycretin compound page, all human trials.

Our Notes on the Compound

Amycretin: A single molecule that activates both GLP-1 and amylin receptors, tested by injection and as a tablet in early obesity trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.