A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes (T2D)
• Intervention / Treatment: Drug: Placebo (NNC0487-0111 subcutanous); Drug: NNC0487-0111 subcutanous; Drug: Placebo (NNC0487-0111 oral); Drug: NNC0487-0111 oral

• Study Type: Interventional
• Enrollment (Actual): 448
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Kyustendil, Bulgaria, 2500
    • Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
  • Kyustendil, Bulgaria, 2500
    • IPSOMC Dr. Miglena Rizova Ltd.
  • Plovdiv, Bulgaria, 4002
    • DCC Sveti Georgi EOOD
  • Plovdiv, Bulgaria, 4001
    • UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
  • Plovdiv, Bulgaria, 4002
    • Diagnostic-Consultative Centre "Sveti Georgi" Eood
  • Plovdiv, Bulgaria, 4001
    • UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
  • Sofia, Bulgaria, 1431
    • USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
  • Sofia, Bulgaria, 1431
    • UMHAT "Aleksandrovska"
  • Sofia, Bulgaria, 1000
    • Medical centre Regina Life Clinic EOOD
  • Sofia, Bulgaria, 1431
    • USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
  • Varna, Bulgaria, 9020
    • AIPSMC Dr. Artin Magardichyan EOOD
• Croatia
  • Karlovac, Croatia, 47000
    • Opca bolnica Karlovac
  • Krapinske Toplice, Croatia, 49217
    • Specijalna bolnica Krapinske Toplice - Endokrinologija
  • Krapinske Toplice, Croatia, 49217
    • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
  • Osijek, Croatia, 31 000
    • Klinicki bolnicki centar Osijek
  • Osijek, Croatia, 31 000
    • Klinicki bolnicki centar Osijek_Endocrinology
  • Varaždin, Croatia, 42 000
    • Opca bolnica Varazdin_Endocrinology
  • Varaždin, Croatia, 42 000
    • Opca bolnica Varazdin
  • City of Zagreb
    • Zagreb, City of Zagreb, Croatia, 10000
      • Poliklinika Solmed
  • Primorje-Gorski Kotar County
    • Rijeka, Primorje-Gorski Kotar County, Croatia, 51 000
      • KBC Rijeka, Endokrinologija
    • Rijeka, Primorje-Gorski Kotar County, Croatia, 51 000
      • Clinical Hospital Centre Rijeka_Endocrinology
• Germany
  • Elsterwerda, Germany, 04910
    • Zentrum fuer Klinische Studien Suedbrandenburg GmbH
  • Essen, Germany, 45136
    • InnoDiab Forschung GmbH
  • Hamburg, Germany, 22607
    • Wendisch/Dahl Hamburg
  • Hamburg, Germany, 22607
    • Wendisch/Dahl Hamburg (DZHW)
  • Münster, Germany, 48145
    • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  • Oldenburg in Holstein, Germany, 23758
    • RED-Institut für medizinische Forschung und Fortbildung GmbH
• Greece
  • Athens, Greece, 115 25
    • Iatriko Psychicou Private Clinic
  • Athens, Greece, 12462
    • U.G.H of Athens "Attikon"
  • Goudi/Athens, Greece, 11527
    • "Laiko" General Hospital of Athens
  • Thessaloniki, Greece, GR-54643
    • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
  • Thessaloniki, Greece, GR-57001
    • "Thermi" Private Hosital
  • Thessaloniki, Greece, 564 29
    • 424 Military General Training Hospital
  • Thessaloniki, Greece, 57001
    • "Thermi" Private Hosital
  • Thessaloniki, Greece, 54645
    • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
  • Thessaloniki, Greece, 564 29
    • 424 Military General Training Hospital - 2nd Department of Internal Medicine
• Hungary
  • Budapest, Hungary, 1106
    • Bajcsy-Zsilinszky Kórház
  • Budapest, Hungary, 1134
    • Mh Egészségügyi Központ
  • Debrecen, Hungary, 4031
    • Debreceni Egyetem
  • Debrecen, Hungary, H-4031
    • Debreceni Egyetem
  • Debrecen, Hungary, H-4032
    • Debreceni Egyetem
  • Gyula, Hungary, 5700
    • Békés Megyei Központi Kórház
  • Kaposvár, Hungary, H-7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Kaposvár, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem
• Japan
  • Aichi, Japan, 468-0009
    • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
  • Chiba, Japan, 261-0004
    • Tokuyama Clinic
  • Chiba, Japan, 261-0004
    • Tokuyama clinic_Diabetic internal medicine
  • Chiba-shi, Chiba, Japan, 260-0804
    • Akaicho Clinic
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic_Internal medicine
  • Tokyo, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic
  • Tokyo, Japan, 104-0031
    • Fukuwa Clinic
  • Tokyo, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic_Internal Medicine
  • Tokyo, Japan, 104-0031
    • Fukuwa Clinic_Internal Medicine
  • Miyazaki
    • Miyazaki, Miyazaki, Japan, 880-0034
      • Heiwadai Hospital_Internal Medicine
    • Miyazaki, Miyazaki, Japan, 880-0034
      • Heiwadai Hospital
• Poland
  • Bialystok, Poland, 15-375
    • Specderm Poznańska Spółka Jawna
  • Lublin, Poland, 20-718
    • Ekamed Sp. z o.o.
  • Ruda Śląska, Poland, 41-709
    • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
  • Warsaw, Poland, 02-507
    • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-261
      • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
    • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
      • Formed 2 Sp. z o.o.
  • Lower Silesian Voivodeship
    • Legnica, Lower Silesian Voivodeship, Poland, 59-220
      • Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
    • Legnica, Lower Silesian Voivodeship, Poland, 59-220
      • Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-718
      • Ekamed Sp. z o.o.
  • Masovian Voivodeship
    • Siedlce, Masovian Voivodeship, Poland, 08-110
      • ETG Siedlce
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-879
      • NZOZ Vita-Diabetica Malgorzata Buraczyk
    • Bialystok, Podlaskie Voivodeship, Poland, 15-375
      • Specderm Poznanska Sp. j.
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-302
      • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
• Romania
  • Brasov, Romania, 500101
    • Mariodiab Clinic SRL
  • Timișoara, Romania, 300723
    • Spitalul Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara
  • Timișoara, Romania, 300288
    • Cabinet Medical Dr Geru SRL
  • Bihor County
    • Oradea, Bihor County, Romania, 410025
      • SC Grand Med SRL
  • Bucurestii
    • Bucharest, Bucurestii, Romania, 020475
      • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Spitalul Clinic Judetean Urgenta Cluj-Napoca
  • Mureș County
    • Târgu Mureş, Mureș County, Romania, 540142
      • Sc Mediab Srl
  • Prahova
    • Ploieşti, Prahova, Romania, 100018
      • Novus Medical Clinica SRL
• Slovakia
  • Poprad, Slovakia, 05801
    • Dentavia s.r.o.
  • Prešov, Slovakia, 080 01
    • DIABETOL, s.r.o.
  • Rimavská Sobota, Slovakia, 979 01
    • OLIVER - MED s.r.o.
  • Žilina, Slovakia, 010 01
    • MEDIVASA, s.r.o., Diabetologicka ambulancia
  • Slovak Republic
    • Šahy, Slovak Republic, Slovakia, 93601
      • Peter Farkas MD, s.r.o.
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain, 08036
    • Hospital Clinic I Provincial
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañón
  • Santander, Spain, 39008
    • Hospital Universitario Marques de Valdecilla
  • Seville, Spain, 41003
    • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Seville, Spain, 41010
    • Hospital Infanta Luisa
  • Seville, Spain, 41950
    • Hospital Vithas Sevilla
  • Seville, Spain, 41950
    • Hospital Nisa Sevilla Aljarafe
• United States
  • California
    • Santa Ana, California, United States, 92701
      • Southern Cal Clinical Research
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research LLC
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Fleming Island Ctr for Clin Res
    • Hollywood, Florida, United States, 33024
      • Encore Medical Research LLC
    • Miramar, Florida, United States, 33027
      • South Broward Research LLC
    • Orlando, Florida, United States, 32825
      • Florida Inst For Clin Res
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Cedar-Crosse Research Center
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Advanced Internal Medicine, PLLC
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Medstar Research Institute_Hyattsville
    • Oxon Hill, Maryland, United States, 20745
      • Md Medical Research
  • Michigan
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare, PLC
    • Troy, Michigan, United States, 48098
      • Arcturus HC PLC Troy Med Res
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
  • New York
    • Albany, New York, United States, 12203
      • AMC Community Endocrinology
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Lucas Research Inc.
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare/Research
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Plains Clinical Research Center, LLC_Fargo
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians_Pittsburgh
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates
    • Nashville, Tennessee, United States, 37203
      • MidState Endocrine Associates
  • Texas
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
    • Houston, Texas, United States, 77024
      • Victorium Clinical Research
    • Houston, Texas, United States, 77079
      • PlanIt Research, PLLC
    • Houston, Texas, United States, 77061
      • Synergy Groups Medical
    • Lampasas, Texas, United States, 76550
      • Radiance Clinical Research
    • McKinney, Texas, United States, 75069
      • Tekton Research
    • Waco, Texas, United States, 76708
      • Hillcrest Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
• Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
• HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
• Body mass index between greater or equal to 23.0 and below 50.0 kg/m^2.
• Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.

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. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. 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 question.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo subcutaneous; Placebo for subcutaneous treatment	Drug: Placebo (NNC0487-0111 subcutanous); NNC0487-0111 placebo administered subcutanously (under the skin)
Experimental: NNC0487-0111 subcutaneous dose 1; NNC0487-0111 subcutaneous dose 1 treatment	Drug: NNC0487-0111 subcutanous; NNC0487-0111 administered subcutanously (under the skin)
Experimental: NNC0487-0111 subcutaneous dose 2; NNC0487-0111 subcutaneous dose 2 treatment	Drug: NNC0487-0111 subcutanous; NNC0487-0111 administered subcutanously (under the skin)
Experimental: NNC0487-0111 subcutaneous dose 3; NNC0487-0111 subcutaneous dose 3 treatment	Drug: NNC0487-0111 subcutanous; NNC0487-0111 administered subcutanously (under the skin)
Experimental: NNC0487-0111 subcutaneous dose 4; NNC0487-0111 subcutaneous dose 4 treatment	Drug: NNC0487-0111 subcutanous; NNC0487-0111 administered subcutanously (under the skin)
Experimental: NNC0487-0111 subcutaneous dose 5; NNC0487-0111 subcutaneous dose 5 treatment	Drug: NNC0487-0111 subcutanous; NNC0487-0111 administered subcutanously (under the skin)
Experimental: NNC0487-0111 subcutaneous dose 6; NNC0487-0111 subcutaneous dose 6 treatment	Drug: NNC0487-0111 subcutanous; NNC0487-0111 administered subcutanously (under the skin)
Placebo Comparator: Placebo oral; Placebo for oral treatment	Drug: Placebo (NNC0487-0111 oral); NNC0487-0111 placebo administered orally (in the mouth)
Experimental: NNC0487-0111 oral dose 1; NNC0487-0111 oral dose 1 treatment	Drug: NNC0487-0111 oral; NNC0487-0111 administered orally (in the mouth)
Experimental: NNC0487-0111 oral dose 2; NNC0487-0111 oral dose 2 treatment	Drug: NNC0487-0111 oral; NNC0487-0111 administered orally (in the mouth)
Experimental: NNC0487-0111 oral dose 3; NNC0487-0111 oral dose 3 treatment	Drug: NNC0487-0111 oral; NNC0487-0111 administered orally (in the mouth)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	percent point	From baseline (week 0) to end of treatment (week 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in triglycerides	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Relative change in body weight	percent	From baseline (week 0) to end of treatment (week 36)
Change in body weight	kg	From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)	mmol/L	From baseline (week 0) to end of treatment (week 36)
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)	percent points	From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)	kg/m^2	From baseline (week 0) to end of treatment (week 36)
Change in waist circumference	cm	From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)	mmHg	From baseline (week 0) to end of treatment (week 36)
Change in average 24-hour systolic blood pressure (SBP)	mmHg	From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive Protein (hsCRP)	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Number of adverse events	Count of events	From baseline (week 0) to end of study (week 40)
Change in Urinary Albumin/Creatinine Ratio (UACR)	Ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g)	Count of participant	At end of treatment (week 36)
Change in eGFR creatinine- and cystatin C based CKD-EPI	mL/min/1.73 m^2	From baseline (week 0) to end of treatment (week 36)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 24, 2025

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9490-7678; U1111-1296-9708 (Other Identifier: World Health Organization (WHO)); 2023-509412-28 (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