Heart Failure / NNC0537-1482 · Phase 1 Trial

A Research Study on the Effects of NNC0537-1482 in Participants With Heart Failure

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 trial registration for NNC0537-1482, a novel agent in development for heart failure. The study is currently recruiting and has not yet reported results; it is designed to evaluate safety, tolerability, and pharmacokinetics over 64 days in 36 participants randomized to active drug or placebo.

What was studied

Phase 1, Interventional, Randomized, Sequential, Quadruple masking, Treatment purpose. Heart Failure; age from 40 Years; to 75 Years. Intervention: Cohort 1A; Cohort 2A; Cohort 3A; Cohort 4A; Cohort 5A; Cohort B. Compared with: Placebo — Placebo Comparator. n = 36. 1 site: United Kingdom.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 1 safety and tolerability study in a planned enrollment of 36 participants; no results are yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Number of treatment emergent adverse events (TEAE) (assessed at From pre-dose on day 1 until completion of the end of study (day 64))

DesignPhase 1, Interventional, Randomized, Sequential, Quadruple masking, Treatment purpose

PopulationHeart Failure; age from 40 Years; to 75 Years

Sample size36

InterventionCohort 1A; Cohort 2A; Cohort 3A; Cohort 4A; Cohort 5A; Cohort B

ComparatorPlacebo — Placebo Comparator

Setting1 site: United Kingdom

Reported figures

Quoted from the source exactly as published.

Planned enrollment36

PhasePHASE 1

Primary outcome measureNumber of treatment emergent adverse events (TEAE), from pre-dose on day 1 until completion of end of study (day 64)

Study durationup to 64 days (plus screening period up to 28 days)

Caveats

This is a registry record only; no clinical trial results have been reported.
Phase 1 is not designed to assess efficacy or clinical benefit.
Specific inclusion/exclusion criteria, baseline characteristics, and detailed methodology are not provided in this summary.
Recruitment status is active; trial is not yet complete.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1, randomized, placebo-controlled design appropriate for safety assessment.

Directness

limited

Phase 1 focused on safety and tolerability, not efficacy or clinical outcomes.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Study not yet complete; bias risk cannot be evaluated without methodology and results.

Sample adequacy

limited

Estimated enrollment 36 participants is typical for Phase 1 safety studies.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07218627). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 36 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DRUG: NNC0537-1482; DRUG: Placebo. Primary outcome measures: Number of treatment emergent adverse events (TEAE) , From pre-dose on day 1 until completion of the end of study (day 64). Brief summary: The study is testing a new drug (NNC0537-1482) to potentially treat people with heart failure. The purpose of the study is to see if NNC0537-1482 is safe and how it works in the body. Participants will either get NNC0537-1482 or placebo (a "dummy drug" without any active ingredients) and which treatment they get is decided by chance. This study will last up to 64 days with an additional screening period up to 28 days.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07218627Heart FailureNovo NordiskNNC0537-1482