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

Last updated: April 23, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Prevention

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

Placebo (NNC0487-0111 subcutanous)

Placebo (NNC0487-0111 oral)

NNC0487-0111 subcutanous

Clinical Study ID

NCT06542874
NN9490-7678
U1111-1296-9708
2023-509412-28
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, aged 18-75 years (both inclusive) at the time of signing theinformed consent.

  • Diagnosed with type 2 diabetes mellitus greater or equal to 180 days beforescreening.

  • Stable daily dose(s) greater or equal to 90 days before screening of the followingantidiabetic drug(s) or combination regimen(s) at effective or maximum tolerateddose 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 centrallaboratory 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 glucosemonitoring (CGM) device provided for the study, as judged by the investigator.

Exclusion

Exclusion Criteria:

  • Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria within 90 days before screening. However, shortterm insulin treatment for a maximum of 14 consecutive days and prior insulintreatment for gestational diabetes are allowed.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination.

  • Known hypoglycaemic unawareness as indicated by the investigator according toClarke's questionnaire question.

Study Design

Total Participants: 432
Treatment Group(s): 4
Primary Treatment: Placebo (NNC0487-0111 subcutanous)
Phase: 2
Study Start date:
August 07, 2024
Estimated Completion Date:
October 24, 2025

Connect with a study center

  • Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.

    Kyustendil, 2500
    Bulgaria

    Site Not Available

  • Diagnostic-Consultative Centre "Sveti Georgi" Eood

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases

    Plovdiv, 4001
    Bulgaria

    Site Not Available

  • Medical centre Regina Life Clinic EOOD

    Sofia, 1000
    Bulgaria

    Site Not Available

  • UMHAT "Aleksandrovska"

    Sofia, 1431
    Bulgaria

    Site Not Available

  • USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology

    Sofia, 1431
    Bulgaria

    Site Not Available

  • AIPSMC Dr. Artin Magardichyan EOOD

    Varna, 9020
    Bulgaria

    Site Not Available

  • Poliklinika Solmed

    Zagreb, Grad Zagreb 10000
    Croatia

    Site Not Available

  • KBC Rijeka, Endokrinologija

    Rijeka, Primorsko - Goranska Županija 51 000
    Croatia

    Site Not Available

  • Opca bolnica Karlovac

    Karlovac, 47000
    Croatia

    Site Not Available

  • Specijalna bolnica Krapinske Toplice - Endokrinologija

    Krapinske Toplice, 49217
    Croatia

    Site Not Available

  • Klinicki bolnicki centar Osijek

    Osijek, 31 000
    Croatia

    Site Not Available

  • Opca bolnica Varazdin

    Varazdin, 42 000
    Croatia

    Site Not Available

  • Zentrum fuer klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910
    Germany

    Site Not Available

  • InnoDiab Forschung GmbH

    Essen, 45136
    Germany

    Site Not Available

  • Wendisch/Dahl Hamburg

    Hamburg, 22607
    Germany

    Site Not Available

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145
    Germany

    Site Not Available

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758
    Germany

    Site Not Available

  • Iatriko Psychicou Private Clinic

    Athens, 115 25
    Greece

    Site Not Available

  • U.G.H of Athens "Attikon"

    Athens, 12462
    Greece

    Site Not Available

  • "Laiko" General Hospital of Athens

    Goudi/Athens, 11527
    Greece

    Site Not Available

  • "Thermi" Private Hosital

    Thessaloniki, 57001
    Greece

    Site Not Available

  • 424 Military General Training Hospital

    Thessaloniki, 564 29
    Greece

    Site Not Available

  • EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes

    Thessaloniki, 54643
    Greece

    Site Not Available

  • Bajcsy-Zsilinszky Kórház

    Budapest, 1106
    Hungary

    Site Not Available

  • MH Egészségügyi Központ

    Budapest, 1134
    Hungary

    Site Not Available

  • Debreceni Egyetem

    Debrecen, 4031
    Hungary

    Site Not Available

  • Békés Megyei Központi Kórház

    Gyula, 5700
    Hungary

    Site Not Available

  • Somogy Vármegyei Kaposi Mór Oktató Kórház

    Kaposvár, H-7400
    Hungary

    Site Not Available

  • Heiwadai Hospital

    Miyazaki-shi, Miyazaki 880-0034
    Japan

    Site Not Available

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009
    Japan

    Site Not Available

  • Tokuyama clinic

    Chiba, 261-0004
    Japan

    Site Not Available

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804
    Japan

    Site Not Available

  • Naka Kinen Clinic

    Ibaraki, 311-0113
    Japan

    Active - Recruiting

  • Fukuwa Clinic

    Tokyo, 104-0031
    Japan

    Site Not Available

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.

    Legnica, Dolnośląskie 59-220
    Poland

    Site Not Available

  • Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET

    Krakow, Malopolskie 31-261
    Poland

    Site Not Available

  • Formed 2 Sp. z o.o.

    Oswiecim, Malopolskie 32-600
    Poland

    Site Not Available

  • ETG Siedlce

    Siedlce, Masovian 08-110
    Poland

    Site Not Available

  • Specderm Poznańska Spółka Jawna

    Bialystok, Podlaskie 15-375
    Poland

    Site Not Available

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship 15-879
    Poland

    Site Not Available

  • Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia

    Lodz, Wojewodztwo Lodzkie 90-302
    Poland

    Site Not Available

  • EKAMED sp. z o.o.

    Lublin, 20-718
    Poland

    Site Not Available

  • Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.

    Ruda Slaska, 41-709
    Poland

    Site Not Available

  • PANSTWOWY INSTYTUT MEDYCZNY MSWiA

    Warszawa, 02-507
    Poland

    Site Not Available

  • SC Grand Med SRL

    Oradea, Bihor 410025
    Romania

    Site Not Available

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucurestii 020475
    Romania

    Site Not Available

  • Spitalul Clinic Judetean Urgenta Cluj-Napoca

    Cluj Napoca, Cluj 400006
    Romania

    Site Not Available

  • Sc Mediab Srl

    Tirgu Mures, Mures 540142
    Romania

    Site Not Available

  • Novus Medical Clinica SRL

    Ploiesti, Prahova 100018
    Romania

    Site Not Available

  • Mariodiab Clinic SRL

    Brasov, 500101
    Romania

    Site Not Available

  • Cabinet Medical Dr Geru SRL

    Timisoara, 300288
    Romania

    Site Not Available

  • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara

    Timisoara, 300723
    Romania

    Site Not Available

  • Peter Farkas MD, s.r.o.

    Sahy, Slovak Republic 93601
    Slovakia

    Site Not Available

  • DENTAVIA s.r.o.

    Poprad, 05801
    Slovakia

    Site Not Available

  • DIABETOL, s.r.o.

    Presov, 080 01
    Slovakia

    Site Not Available

  • OLIVER - MED s.r.o.

    Rimavska Sobota, 979 01
    Slovakia

    Site Not Available

  • MEDIVASA, s.r.o., Diabetologicka ambulancia

    Zilina, 010 01
    Slovakia

    Site Not Available

  • Hospital Clinic i Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Vithas Sevilla

    Castilleja Dela Cuesta Sevilla, 41950
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruña

    La Coruña, 15006
    Spain

    Site Not Available

  • Hospital Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Site Not Available

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Sevilla, 41003
    Spain

    Site Not Available

  • Hospital Infanta Luisa

    Sevilla, 41010
    Spain

    Site Not Available

  • Hospital Nisa Sevilla Aljarafe

    Sevilla, 41950
    Spain

    Site Not Available

  • Southern Cal Clinical Research

    Santa Ana, California 92701
    United States

    Site Not Available

  • Southern California Dermatology

    Santa Ana, California 92701
    United States

    Site Not Available

  • Chase Medical Research LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Fleming Island Ctr for Clin Res

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Encore Medical Research LLC

    Hollywood, Florida 33024
    United States

    Site Not Available

  • South Broward Research LLC

    Miramar, Florida 33027
    United States

    Active - Recruiting

  • Florida Inst For Clin Res

    Orlando, Florida 32825
    United States

    Site Not Available

  • Cedar-Crosse Research Center

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Advanced Internal Medicine, PLLC

    Paducah, Kentucky 42001
    United States

    Site Not Available

  • Medstar Research Institute_Hyattsville

    Hyattsville, Maryland 20782
    United States

    Site Not Available

  • MD Medical Research

    Oxon Hill, Maryland 20745
    United States

    Site Not Available

  • Arcturus Healthcare, PLC

    Troy, Michigan 48098
    United States

    Site Not Available

  • Clinical Research Professionals

    Chesterfield, Missouri 63005
    United States

    Site Not Available

  • Albany Medical College - Endo

    Albany, New York 12203
    United States

    Site Not Available

  • Lucas Research Inc.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Piedmont Healthcare/Research

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Plains Clinical Research Center, LLC_Fargo

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Preferred Primary Care Physicians_Pittsburgh

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • Health Concepts

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • MidState Endocrine Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • PrimeCare Medical Group

    Houston, Texas 77024
    United States

    Site Not Available

  • Synergy Groups Medical

    Houston, Texas 77061
    United States

    Site Not Available

  • Victorium Clinical Research

    Houston, Texas 77024
    United States

    Site Not Available

  • Fmc Science, Llc

    Lampasas, Texas 76550
    United States

    Site Not Available

  • Radiance Clinical Research

    Lampasas, Texas 76550
    United States

    Site Not Available

  • Tekton Research

    McKinney, Texas 75069
    United States

    Site Not Available

  • Hillcrest Family Health Center

    Waco, Texas 76708
    United States

    Site Not Available

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