Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: NNC0487-0111
    NNC0487-0111 will be administered subcutaneously.
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.
  • Drug: Placebo (matched to NNC0487-0111)
    Placebo will be administered subcutaneously.

Recruiting Locations

Pinnacle Research Group LLC
Anniston, Alabama 36207

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Florida Inst For Clin Res LLC
Orlando, Florida 32825

Midwest Inst For Clin Res
Indianapolis, Indiana 46260

Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina 27405

PMG Research of Wilmington LLC
Wilmington, North Carolina 28401

UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania 19104

Clinical Res Collaborative
Cumberland, Rhode Island 02864

UT Southwestern Med Cntr
Dallas, Texas 75390-9302

Selma Medical Associates
Winchester, Virginia 22601-3834

Rainier Clin Res Ctr Inc
Renton, Washington 98057

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.