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

NCT07415954 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: NN9662-8160U1111-1324-03102025-523260-20
• Study Type: interventional
• Target: 270
• Locations: 10 countries
• Sites: 63

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

Outcome Measures

Primary Outcomes (3)

• Change in glycated haemoglobin (HbA1c) (week 16)

  Measured as percentage-point (%-point).

  From baseline (week 0) to week 16

• Change in HbA1c (week 28)

  Measured as %-point.

  From baseline (week 0) to week 28

• Change in HbA1c (week 40)

  Measured as %-point.

  From baseline (week 0) to week 40

Secondary Outcomes (14)

• Relative change in body weight

  From baseline (week 0) to (week 40)

• Change in body weight

  From baseline (week 0) to (week 40)

• Change in HbA1c

  From baseline (week 0) to (week 16, 28 and 40)

• Change in Fasting Plasma Glucose (FPG)

  From baseline (week 0) to (week 16, 28 and 40)

• Change in Body Mass Index (BMI)

  From baseline (week 0) to (week 40)

Study Arms (3)

NNC0662-0419

EXPERIMENTAL

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

Drug: NNC0662-0419

Semaglutide

ACTIVE COMPARATOR

Participants will receive semaglutide s.c. once weekly.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

NNC0662-0419 DRUG

NNC0662-0419 will be administered subcutaneously.

NNC0662-0419

Semaglutide DRUG

Semaglutide will be administered subcutaneously.

Semaglutide

Placebo DRUG

Placebo will be administered subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (63)

First Valley Medical Group

Lancaster, California, 93534, United States

RECRUITING

Torrance Clinical Research Institute, Inc.

Lomita, California, 90717, United States

RECRUITING

Ark Clinical Research

Long Beach, California, 90815, United States

RECRUITING

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

RECRUITING

Wetlin Research Associates, Inc.

San Diego, California, 92120, United States

RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

RECRUITING

Encore Medical Research LLC

Hollywood, Florida, 33024, United States

RECRUITING

Bioclinical Research Alliance

Miami, Florida, 33155, United States

RECRUITING

South Broward Research LLC

Miramar, Florida, 33027, United States

RECRUITING

West Orange Endocrinology

Ocoee, Florida, 34761, United States

NOT YET RECRUITING

Encore Medical Research of Weston

Weston, Florida, 33331, United States

RECRUITING

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

RECRUITING

Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115-5804, United States

NOT YET RECRUITING

Headlands Research

Springfield, Missouri, 65807, United States

RECRUITING

PharmQuest

Greensboro, North Carolina, 27408, United States

RECRUITING

Piedmont Healthcare Statesville

Statesville, North Carolina, 28625, United States

RECRUITING

Providence Center for Clinical Research

Dayton, Ohio, 45439, United States

RECRUITING

CNS Healthcare

Memphis, Tennessee, 38119, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9302, United States

RECRUITING

JCCT- Juno NW Houston

Houston, Texas, 77040, United States

RECRUITING

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

RECRUITING

Frontier Clinical Research - Kingwood

Kingwood, West Virginia, 26537, United States

NOT YET RECRUITING

Opca bolnica Karlovac

Karlovac, 47000, Croatia

RECRUITING

Poliklinika SLAVONIJA OSIJEK

Osijek, 31000, Croatia

RECRUITING

Opca bolnica Varazdin_Endocrinology

Varaždin, 42 000, Croatia

RECRUITING

Poliklinika Solmed

Zagreb, 10000, Croatia

RECRUITING

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád, 6725, Hungary

NOT YET RECRUITING

Debreceni Egyetem

Debrecen, Hajdú-Bihar, 4032, Hungary

NOT YET RECRUITING

Debreceni Egyetem

Debrecen, 4031, Hungary

NOT YET RECRUITING

Akaicho Clinic_Diabetes Internal Medicine

Chiba-shi, Chiba, 260-0804, Japan

RECRUITING

Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan

RECRUITING

Soka Sugiura Internal Medicine Clinic

Soka-shi, Saitama, 340-0015, Japan

RECRUITING

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

RECRUITING

ToCROM Clinic_Internal Medicine

Tokyo, 160-0008, Japan

RECRUITING

"Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

Bialystok, Podlaskie Voivodeship, 15-351, Poland

NOT YET RECRUITING

Terpa Sp. z o.o. Sp. k.

Lublin, 20-333, Poland

NOT YET RECRUITING

Formed 2 Sp. z o.o.

Oświęcim, 32-600, Poland

RECRUITING

PANSTWOWY INSTYTUT MEDYCZNY MSWiA

Warsaw, 02-507, Poland

RECRUITING

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

Zabrze, 41-800, Poland

RECRUITING

Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos

Coimbra, 3000-150, Portugal

RECRUITING

Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda

Ponte de Lima, 4990-029, Portugal

RECRUITING

Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos

Vila do Conde, 4480-565, Portugal

RECRUITING

Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia

Vila Nova de Gaia, 4400-346, Portugal

RECRUITING

DIADA, s.r.o.

Bardejov, 08501, Slovakia

RECRUITING

Metabol KLINIK s.r.o.

Bratislava, 811 08, Slovakia

RECRUITING

Diacrin s. r. o.

Bratislava, 83101, Slovakia

RECRUITING

SIN AZUCAR s.r.o.

Malacky, 901 01, Slovakia

RECRUITING

Korea University Ansan Hospital_Endocrinology

Ansan-si, Gyeonggi-do, 15355, South Korea

NOT YET RECRUITING

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

NOT YET RECRUITING

Nowon Eulji Medical Center, Eulji University_Endocrinology

Seoul, 01830, South Korea

NOT YET RECRUITING

Kangbuk Samsung Hospital_Endocrinology

Seoul, 03181, South Korea

NOT YET RECRUITING

Centro de Salud A Estrada

A Estrada, 36680, Spain

NOT YET RECRUITING

Equip D´Atencio Primaria Barcelona Sardenya

Barcelona, 08025, Spain

RECRUITING

Hospital Vithas Sevilla

Castilleja de la Cuesta, 41950, Spain

RECRUITING

Clínica Bofill

Girona, 17002, Spain

RECRUITING

ABS La Roca del Vallés_Endocrinología

La Roca Del Vallés, 08430, Spain

RECRUITING

Centro de Saúde Concepción Arenal

Santiago de Compostela, 15701, Spain

NOT YET RECRUITING

Ramathibodi Hospital

Bangkok, 10400, Thailand

NOT YET RECRUITING

Siriraj Hospital

Bangkok, 10700, Thailand

NOT YET RECRUITING

Maharaj Nakorn Chiang Mai

Chiang Mai, 50200, Thailand

NOT YET RECRUITING

Srinagarind Hospital

Khon Kaen, 40002, Thailand

NOT YET RECRUITING

Maharat Nakhon Ratchasima Hospital

Nakhon Ratchasima, 30000, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): September 3, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

PL (5); KR (4); PT (4); SL (4); JP (5); HU (3); US (23); ES (6); TH (5); CR (4)