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Purpose

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female (sex at birth). - Age 18-75 years (both inclusive) at the time of signing the informed consent. - Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole [mmol/mol]) (both inclusive) as assessed by central laboratory at screening. - Willingness to obtain a high weight loss (greater than [>] 25% of weight at baseline).

Exclusion Criteria

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. - Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.

Study Design

Phase
Phase 2
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
NNC0662-0419 		Participants will receive NNC0662-0419 subcutaneously (s.c.) in a dose escalating manner once weekly.
  • Drug: NNC0662-0419
    NNC0662-0419 will be administered subcutaneously.
Active Comparator
Semaglutide 		Participants will receive semaglutide s.c. once weekly.
  • Drug: Semaglutide
    Semaglutide will be administered subcutaneously.
Placebo Comparator
Placebo 		Participants will receive placebo matched to their respective investigational medicinal product s.c. once weekly.
  • Drug: Placebo
    Placebo will be administered subcutaneously.

Recruiting Locations

First Valley Medical Group
Lancaster, California 93534

Torrance Clinical Research Institute, Inc.
Lomita, California 90717

Ark Clinical Research
Long Beach, California 90815

Pacific Clinical Studies
Los Alamitos, California 90720

Wetlin Research Associates, Inc.
San Diego, California 92120

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Encore Medical Research LLC
Hollywood, Florida 33024

Bioclinical Research Alliance
Miami, Florida 33155

South Broward Research LLC
Miramar, Florida 33027

Encore Medical Research of Weston
Weston, Florida 33331

Elite Clinical Trials
Blackfoot, Idaho 83221

Cedar-Crosse Research Center
Chicago, Illinois 60607

Headlands Research
Springfield, Missouri 65807

PharmQuest
Greensboro, North Carolina 27408

Piedmont Healthcare Statesville
Statesville, North Carolina 28625

Providence Center for Clinical Research
Dayton, Ohio 45439

CNS Healthcare
Memphis, Tennessee 38119

University of Texas Southwestern Medical Center
Dallas, Texas 75390-9302

JCCT- Juno NW Houston
Houston, Texas 77040

Consano Clinical Research, LLC
Shavano Park, Texas 78231

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.