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

May 18, 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • 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 Locations

  • Croatia
      • Karlovac, Croatia, 47000
        • Recruiting
        • Opća 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
        • Recruiting
        • Akaicho Clinic_Diabetes Internal Medicine
      • Ibaraki, Japan, 311-0113
        • Recruiting
        • Naka Kinen Clinic_Internal medicine
      • Soka-shi, Saitama, Japan, 340-0015
        • Recruiting
        • Soka Sugiura Internal Medicine Clinic
      • Tokyo, Japan, 103-0027
        • Recruiting
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 160-0008
        • 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
        • PANSTWOWY 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
        • Not yet 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
        • Not yet recruiting
        • Nowon Eulji Medical Center, Eulji University_Endocrinology
      • Seoul, South Korea, 03181
        • Not yet recruiting
        • Kangbuk Samsung Hospital_Endocrinology
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, South Korea, 15355
        • Not yet recruiting
        • Korea University Ansan Hospital_Endocrinology
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Not yet recruiting
        • Pusan National University Yangsan Hospital
  • 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
      • La Roca Del Vallés, Spain, 08430
        • Recruiting
        • ABS La Roca del Vallés_Endocrinología
      • Santiago de Compostela, Spain, 15701
        • Not yet recruiting
        • Centro de Saúde Concepción Arenal
  • Thailand
      • Bangkok, Thailand, 10700
        • Not yet recruiting
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Not yet recruiting
        • Ramathibodi Hospital
      • Chiang Mai, Thailand, 50200
        • Not yet recruiting
        • Maharaj Nakorn Chiang Mai
      • Khon Kaen, Thailand, 40002
        • Not yet recruiting
        • Srinagarind Hospital
      • Nakhon Ratchasima, Thailand, 30000
        • Not yet 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

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
Intervention / Treatment
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

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

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 44)
Measured as number of events.
From baseline (week 0) to (week 44)

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

  • 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)

April 17, 2026

Primary Completion (Estimated)

September 3, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9662-8160
  • 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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