Recruiting
Phase 3

NNC0487-0111

Sponsor:

Novo Nordisk A/S

Code:

NCT07503210

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0487-0111

Placebo (matched to NNC0487-0111)

Study Details

Brief summary:

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Conditions

Obesity

Study ID

NCT07503210

Start date

Apr 21, 2026

Status verified date

Jul, 2026

Completion date

Jul 4, 2028

Anticipated

Primary completion date

Jun 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.

Exclusion Criteria:

  • Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% \[48 millimoles per mole (mmol/mol)\] as measured by the central laboratory at screening.
  • History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
  • Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP 1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC0487-0111

Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

placebo comparator: Placebo

Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Interventions

NNC0487-0111

NNC0487-0111 will be administered subcutaneously.

Placebo (matched to NNC0487-0111)

Placebo will be administered subcutaneously.

Primary outcome measure

  • Relative change in body weight [ Time Frame: From week 40 to week 92 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Pinnacle Research Group LLC

Recruiting

Anniston, Alabama, United States, 36207

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Florida Inst For Clin Res LLC

Recruiting

Orlando, Florida, United States, 32825

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60077

Midwest Inst For Clin Res

Recruiting

Indianapolis, Indiana, United States, 46260

Medication Mgmnt, LLC_Grnsboro

Recruiting

Greensboro, North Carolina, United States, 27405

PMG Research of Wilmington LLC

Recruiting

Wilmington, North Carolina, United States, 28401

UPA Ctr Weight and Eating Dis

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Res Collaborative

Recruiting

Cumberland, Rhode Island, United States, 02864

UT Southwestern Med Cntr

Recruiting

Dallas, Texas, United States, 75390-9302

Selma Medical Associates

Recruiting

Winchester, Virginia, United States, 22601-3834

Rainier Clin Res Ctr Inc

Recruiting

Renton, Washington, United States, 98057

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-07-09.