Recruiting
Phase 2

NNC0662-0419

Sponsor:

Novo Nordisk A/S

Code:

NCT07415954

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NNC0662-0419

Semaglutide

Placebo

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT07415954

Start date

Apr 17, 2026

Status verified date

Aug, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Sep 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NNC0662-0419

Participants will receive NNC0662-0419 subcutaneously (s.c.) in a dose escalating manner once weekly.

active comparator: Semaglutide

Participants will receive semaglutide s.c. once weekly.

placebo comparator: Placebo

Participants will receive placebo matched to their respective investigational medicinal product s.c. once weekly.

Interventions

NNC0662-0419

NNC0662-0419 will be administered subcutaneously.

Semaglutide

Semaglutide will be administered subcutaneously.

Placebo

Placebo will be administered subcutaneously.

Primary outcome measure

  • Change in glycated haemoglobin (HbA1c) (week 16) [ Time Frame: From baseline (week 0) to week 16 ]
  • Change in HbA1c (week 28) [ Time Frame: From baseline (week 0) to week 28 ]
  • Change in HbA1c (week 40) [ Time Frame: From baseline (week 0) to week 40 ]

Central Contacts and Locations

Locations

First Valley Medical Group

Recruiting

Lancaster, California, United States, 93534

Torrance Clinical Research Institute, Inc.

Recruiting

Lomita, California, United States, 90717

Ark Clinical Research

Recruiting

Long Beach, California, United States, 90815

Pacific Clinical Studies

Recruiting

Los Alamitos, California, United States, 90720

Wetlin Research Associates, Inc.

Recruiting

San Diego, California, United States, 92120

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Encore Medical Research LLC

Recruiting

Hollywood, Florida, United States, 33024

Bioclinical Research Alliance

Recruiting

Miami, Florida, United States, 33155

South Broward Research LLC

Recruiting

Miramar, Florida, United States, 33027

Encore Medical Research of Weston

Recruiting

Weston, Florida, United States, 33331

Elite Clinical Trials

Recruiting

Blackfoot, Idaho, United States, 83221

Cedar-Crosse Research Center

Recruiting

Chicago, Illinois, United States, 60607

Headlands Research

Recruiting

Springfield, Missouri, United States, 65807

PharmQuest

Recruiting

Greensboro, North Carolina, United States, 27408

Piedmont Healthcare Statesville

Recruiting

Statesville, North Carolina, United States, 28625

Providence Center for Clinical Research

Recruiting

Dayton, Ohio, United States, 45439

CNS Healthcare

Recruiting

Memphis, Tennessee, United States, 38119

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390-9302

JCCT- Juno NW Houston

Recruiting

Houston, Texas, United States, 77040

Consano Clinical Research, LLC

Recruiting

Shavano Park, Texas, United States, 78231

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Aug 10, 2026

Last verified

Aug, 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 2026-08-10.