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Purpose

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Conditions

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 - History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation - Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement - Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m^2)

Exclusion Criteria

  • Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods - Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening - History of type 1 or type 2 diabetes - Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening - Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening - Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cagrilintide 		Participants will receive Cagrilintide for 26 weeks.
  • Drug: Cagrilintide
    Cagrilintide will be administered subcutaneously.
Placebo Comparator
Placebo 		Participants will receive placebo matched to Cagrilintide for 26 weeks.
  • Drug: Placebo (matched to Cagrilintide)
    Placebo matched to Cagrilintide will be administered subcutaneously.

Recruiting Locations

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Northeast Research Institute
Fleming Island, Florida 32003

Jacksonville Ctr For Clin Res
Jacksonville, Florida 32216

Center for Diab,Obes & Metab
Pembroke Pines, Florida 33024

Encore Medical Research of Weston
Weston, Florida 33331

Monroe Biomedical Research, LLC
Monroe, North Carolina 28112

Accellacare
Wilmington, North Carolina 28401

Holston Medical Group_Bristol
Bristol, Tennessee 37620

Amarillo Medical Specialists
Amarillo, Texas 79124

Elligo Clin Res Centre
Austin, Texas 78704

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.