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

Conditions

• Heart Failure
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NNC0487-0111 — DRUG
  NNC0487-011 will be administered subcutaneously.
• Placebo — DRUG
  Placebo will be administered subcutaneously.

Study Details

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.

Key Dates

Start date

May 11, 2026

Status verified

Apr 2026

Primary completion

Jul 23, 2029

Completion

Aug 15, 2029

Study Design

Enrollment

5,610 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NNC0487-0111
  Participants will receive NNC0487-0111 subcutaneously (s.c.) in a dose escalating manner once weekly.
• Placebo Comparator: Placebo
  Participants will receive placebo matched to NNC0487-011 s.c. once weekly.

Primary Outcome Measure

Time to first occurrence of a composite Heart Failure (HF) endpoint consisting of cardiovascular (CV) death [ Time Frame: From baseline (week 0) to 165 weeks ]

Central Contacts

• Novo Nordisk
  (+1) 866-867-7178
  [email protected]

Locations (202)

Find similar trials in Alexander City, AL

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