A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

September 10, 2026 updated by: Novo Nordisk A/S

Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
270

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Croatia
      • Karlovac, Croatia, 47000
        • Recruiting
        • Opca bolnica Karlovac
      • Osijek, Croatia, 31000
        • Recruiting
        • Poliklinika SLAVONIJA OSIJEK
      • Varaždin, Croatia, 42 000
        • Recruiting
        • Opca bolnica Varazdin_Endocrinology
      • Zagreb, Croatia, 10000
        • Recruiting
        • Poliklinika Solmed
  • Hungary
      • Debrecen, Hungary, 4031
        • Not yet recruiting
        • Debreceni Egyetem
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, 6725
        • Not yet recruiting
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Not yet recruiting
        • Debreceni Egyetem
  • Japan
      • Chiba-shi, Chiba, Japan, 260-0804
        • Active, not recruiting
        • Akaicho Clinic_Internal medicine
      • Ibaraki, Japan, 311-0113
        • Active, not recruiting
        • Naka Kinen Clinic_Internal medicine
      • Soka-shi, Saitama, Japan, 340-0015
        • Active, not recruiting
        • Soka Sugiura Internal Medicine Clinic
      • Tokyo, Japan, 103-0027
        • Active, not recruiting
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 160-0008
        • Active, not recruiting
        • ToCROM Clinic_Internal Medicine
  • Poland
      • Lublin, Poland, 20-333
        • Not yet recruiting
        • Terpa Sp. z o.o. Sp. k.
      • Oświęcim, Poland, 32-600
        • Recruiting
        • Formed 2 Sp. z o.o.
      • Warsaw, Poland, 02-507
        • Recruiting
        • Państwowy Instytut Medyczny MSWiA
      • Zabrze, Poland, 41-800
        • Recruiting
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Recruiting
        • "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
  • Portugal
      • Coimbra, Portugal, 3000-150
        • Recruiting
        • Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos
      • Ponte de Lima, Portugal, 4990-029
        • Recruiting
        • Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda
      • Vila Nova de Gaia, Portugal, 4400-346
        • Recruiting
        • Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia
      • Vila do Conde, Portugal, 4480-565
        • Recruiting
        • Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos
  • Slovakia
      • Bardejov, Slovakia, 08501
        • Recruiting
        • DIADA, s.r.o.
      • Bratislava, Slovakia, 83101
        • Recruiting
        • Diacrin s. r. o.
      • Bratislava, Slovakia, 811 08
        • Recruiting
        • Metabol KLINIK s.r.o.
      • Malacky, Slovakia, 901 01
        • Recruiting
        • SIN AZUCAR s.r.o.
  • South Korea
      • Seoul, South Korea, 01830
        • Recruiting
        • Nowon Eulji Medical Center, Eulji University_Endocrinology
      • Seoul, South Korea, 03181
        • Recruiting
        • Kangbuk Samsung Hospital_Endocrinology
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Recruiting
        • Korea University Ansan Hospital_Endocrinology
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital_Family Medicine
  • Spain
      • A Estrada, Spain, 36680
        • Not yet recruiting
        • Centro de Salud A Estrada
      • Barcelona, Spain, 08025
        • Recruiting
        • Equip D´Atencio Primaria Barcelona Sardenya
      • Castilleja de la Cuesta, Spain, 41950
        • Recruiting
        • Hospital Vithas Sevilla
      • Girona, Spain, 17002
        • Recruiting
        • Clínica Bofill
      • Santiago de Compostela, Spain, 15701
        • Recruiting
        • Centro de Saúde Concepción Arenal
    • Barcelona
      • La Roca Del Vallés, Barcelona, Spain, 08430
        • Recruiting
        • ABS La Roca CAP Vicenç_Endocrino
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Srinagarind Hospital
      • Nakhon Ratchasima, Thailand, 30000
        • Recruiting
        • Maharat Nakhon Ratchasima Hospital
  • United States
    • California
      • Lancaster, California, United States, 93534
        • Recruiting
        • First Valley Medical Group
      • Lomita, California, United States, 90717
        • Recruiting
        • Torrance Clinical Research Institute, Inc.
      • Long Beach, California, United States, 90815
        • Recruiting
        • Ark Clinical Research
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Pacific Clinical Studies
      • San Diego, California, United States, 92120
        • Recruiting
        • Wetlin Research Associates, Inc.
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Diablo Clinical Research, Inc.
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Encore Medical Research LLC
      • Miami, Florida, United States, 33155
        • Recruiting
        • Bioclinical Research Alliance
      • Miramar, Florida, United States, 33027
        • Recruiting
        • South Broward Research LLC
      • Ocoee, Florida, United States, 34761
        • Not yet recruiting
        • West Orange Endocrinology
      • Weston, Florida, United States, 33331
        • Recruiting
        • Encore Medical Research of Weston
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Recruiting
        • Elite Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Cedar-Crosse Research Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5804
        • Not yet recruiting
        • Brigham & Women's Hospital
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Headlands Research
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Recruiting
        • PharmQuest
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Piedmont Healthcare Statesville
    • Ohio
      • Dayton, Ohio, United States, 45439
        • Recruiting
        • Providence Center for Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • CNS Healthcare
    • Texas
      • Dallas, Texas, United States, 75390-9302
        • Recruiting
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77040
        • Recruiting
        • JCCT- Juno NW Houston
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Consano Clinical Research, LLC
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Not yet recruiting
        • Frontier Clinical Research - Kingwood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c) (week 16)
Time Frame: From baseline (week 0) to week 16
Measured as percentage-point (%-point).
From baseline (week 0) to week 16
Change in HbA1c (week 28)
Time Frame: From baseline (week 0) to week 28
Measured as %-point.
From baseline (week 0) to week 28
Change in HbA1c (week 40)
Time Frame: From baseline (week 0) to week 40
Measured as %-point.
From baseline (week 0) to week 40

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to (week 40)
Measured as percentage (%).
From baseline (week 0) to (week 40)
Change in body weight
Time Frame: From baseline (week 0) to (week 40)
Measured as kilogram (kg).
From baseline (week 0) to (week 40)
Change in HbA1c
Time Frame: From baseline (week 0) to (week 16, 28 and 40)
Measured as %-point.
From baseline (week 0) to (week 16, 28 and 40)
Change in Fasting Plasma Glucose (FPG)
Time Frame: From baseline (week 0) to (week 16, 28 and 40)
Measured as millimoles per litre (mmol/L).
From baseline (week 0) to (week 16, 28 and 40)
Change in Body Mass Index (BMI)
Time Frame: From baseline (week 0) to (week 40)
Measured in kilograms per square metre (kg/m^2).
From baseline (week 0) to (week 40)
Change in waist circumference
Time Frame: From baseline (week 0) to (week 40)
Measured in centimetre (cm).
From baseline (week 0) to (week 40)
Change in high sensitivity C-Reactive Protein (hsCRP)
Time Frame: From baseline (week 0) to (week 40)
Measured as ratio to baseline.
From baseline (week 0) to (week 40)
Change in total cholesterol
Time Frame: From baseline (week 0) to (week 40)
Measured as ratio to baseline.
From baseline (week 0) to (week 40)
Change in High-Density Lipoprotein (HDL) cholesterol
Time Frame: From baseline (week 0) to (week 40)
Measured as ratio to baseline.
From baseline (week 0) to (week 40)
Change in Low-Density Lipoprotein (LDL) cholesterol
Time Frame: From baseline (week 0) to (week 40)
Measured as ratio to baseline.
From baseline (week 0) to (week 40)
Change in triglycerides
Time Frame: From baseline (week 0) to (week 40)
Measured as ratio to baseline.
From baseline (week 0) to (week 40)
Change in Urine Albumin Creatinine Ratio (UACR)
Time Frame: From baseline (week 0) to (week 16, 28 and 40)
Measured as ratio to baseline.
From baseline (week 0) to (week 16, 28 and 40)
Change in estimated Glomerular Filtration Rate (eGFR) (creatinine cystatin C-based Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] 2021)
Time Frame: From baseline (week 0) to (week 40)
Measured in millilitres per minute per 1.73 square metre (mL/min/1.73 m^2).
From baseline (week 0) to (week 40)
Number of adverse events
Time Frame: From baseline (week 0) to (week 48)
Measured as number of events.
From baseline (week 0) to (week 48)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9662-8160
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • U1111-1324-0310 (Other Identifier: World Health Organization (WHO))
  • 2025-523260-20 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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