NNC0487-0111 / Obesity / Heart Failure · Phase 3 Trial

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

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 3 randomized controlled trial registration for NNC0487-0111 versus placebo in patients with heart failure (HFpEF or HFmrEF) and obesity. The study is still recruiting with no results yet reported in this registry record; the trial design is rigorous but outcome data are not available for clinical assessment.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Heart Failure; age from 18 Years. Intervention: NNC0487-0111. Compared with: Placebo — Placebo Comparator. n = 5,610. 838 sites across 27 countries.

Key findings

Safety

This is a registry record only; no efficacy or safety results are reported.

Who this may help

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

Plain-language summary

This is a Phase 3 RCT registration with no results posted; the study is still recruiting and outcomes have not yet been reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death (assessed at From baseline (week 0) to 165 weeks); Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit (assessed at From baseline (week 0) to 165 weeks)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity, Heart Failure; age from 18 Years

Sample size5,610

InterventionNNC0487-0111

ComparatorPlacebo — Placebo Comparator

Setting838 sites across 27 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment5610

Study phasePhase 3

Primary outcome 1Time to first occurrence of composite HF endpoint consisting of cardiovascular death, from baseline (week 0) to 165 weeks

Primary outcome 2Time to first occurrence of composite HF endpoint consisting of HF hospitalisation or urgent HF visit, from baseline (week 0) to 165 weeks

Caveats

This is a registry record only; no efficacy or safety results are reported.
Study is still recruiting; completion and outcome data are not yet available.
Randomization, blinding, and detailed methods are not described in this registry entry.
No comparative data, effect sizes, or statistical analyses are available at this stage.

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

strong

Phase 3, randomized, placebo-controlled intervention trial design.

Directness

strong

Hard clinical endpoints: cardiovascular death and HF hospitalisation or urgent visit.

Consistency

insufficient

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

Risk of bias

insufficient

Randomization and blinding not detailed in this registry record; methods unavailable.

Sample adequacy

strong

Estimated enrollment 5610 participants; large sample for Phase 3 hard endpoint trial.

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 (NCT07567001). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 5610 participants (ESTIMATED). Conditions: Obesity, Heart Failure. Interventions: DRUG: NNC0487-0111; DRUG: Placebo. Primary outcome measures: Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death , From baseline (week 0) to 165 weeks; Time to first occurrence of a composite HF endpoint consisting of HF hospitalisation or urgent HF visit , From baseline (week 0) to 165 weeks. Brief summary: 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.

Follow from this

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

NNC0487-0111ObesityHeart FailureNovo NordiskNCT07567001