Type 2 Diabetes (T2D)Phase 2NCT06542874
A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
A Phase 2 study testing NNC0487-0111 subcutanous and NNC0487-0111 oral in people with Type 2 Diabetes (T2D), run by Novo Nordisk A/S at 137 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes (T2D)
- What is being tested?
- NNC0487-0111 subcutanous and NNC0487-0111 oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 137 sitesin 11 countries
- Study dates
- 7 Aug 2024to 24 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
137 sites in 11 countries.
137 sites in 11 countries
United States39 sites
AMC Community Endocrinology
Albany, New York, 12203
Uni of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Clinical Research Professionals
Chesterfield, Missouri, 63005
Cedar-Crosse Research Center
Chicago, Illinois, 60607
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
Lillestol Research LLC
Fargo, North Dakota, 58104
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, 58104
Fleming Island Ctr for Clin Res
Fleming Island, Florida, 32003
Encore Medical Research LLC
Hollywood, Florida, 33024
Victorium Clinical Research
Houston, Texas, 77024
Synergy Groups Medical
Houston, Texas, 77061
PlanIt Research, PLLC
Houston, Texas, 77079
Medstar Research Institute_Hyattsville
Hyattsville, Maryland, 20782
Holston Medical Group
Kingsport, Tennessee, 37660
Radiance Clinical Research
Lampasas, Texas, 76550
Velocity Clin Research LA
Los Angeles, California, 90057
Tekton Research
McKinney, Texas, 75069
ActivMed Practice & Research LLC
Methuen, Massachusetts, 01844
South Broward Research LLC
Miramar, Florida, 33027
Centricity Rsrch MHCity Multi
Morehead City, North Carolina, 28557
Clinical Research Associates
Nashville, Tennessee, 37203
MidState Endocrine Associates
Nashville, Tennessee, 37203
Alliance for Multispec Res
Norman, Oklahoma, 73069
Florida Inst For Clin Res
Orlando, Florida, 32825
Florida Institute for Clinical research
Orlando, Florida, 32825
MD Medical Research
Oxon Hill, Maryland, 20745
Advanced Internal Medicine, PLLC
Paducah, Kentucky, 42001
Jefferson Endocrinology Assocs
Philadelphia, Pennsylvania, 19107-6810
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, 15236
Health Concepts
Rapid City, South Dakota, 57702
Southern Cal Clinical Research
Santa Ana, California, 92701
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Arcturus HC PLC Troy Med Res
Troy, Michigan, 48098
Arcturus Healthcare, PLC
Troy, Michigan, 48098
Hillcrest Family Health Center
Waco, Texas, 76708
Chase Medical Research LLC
Waterbury, Connecticut, 06708
Poland14 sites
Specderm Poznanska Sp. j.
Bialystok, Podlaskie Voivodeship, 15-375
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, 15-879
Specderm Poznańska Spółka Jawna
Bialystok, 15-375
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
Krakow, Lesser Poland Voivodeship, 31-261
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220
Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220
Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz, Łódź Voivodeship, 90-302
EKAMED sp. z o.o.
Lublin, Lublin Voivodeship, 20-718
EKAMED sp. z o.o.
Lublin, 20-718
Formed 2 Sp. z o.o.
Oświęcim, Lesser Poland Voivodeship, 32-600
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
Ruda Śląska, Gornoslaskie, 41-709
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
Ruda Śląska, 41-709
ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507
Bulgaria12 sites
Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd.
Kyustendil, 2500
IPSOMC Dr. Miglena Rizova Ltd.
Kyustendil, 2500
UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases
Plovdiv, 4001
UMHAT Kaspela EOOD, Endocrinology and Metabolic Diseases Clinic
Plovdiv, 4001
DCC Sveti Georgi EOOD
Plovdiv, 4002
Diagnostic-Consultative Centre "Sveti Georgi" Eood
Plovdiv, 4002
Medical centre Regina Life Clinic EOOD
Sofia, 1000
UMHAT "Aleksandrovska"
Sofia, 1431
UMHAT Aleksandrovska EAD, Densitometry and Bone Metabolic Diseases
Sofia, 1431
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
Sofia, 1431
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
Sofia, 1431
AIPSMC Dr. Artin Magardichyan EOOD
Varna, 9020
Japan12 sites
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009
Tokuyama clinic_Diabetic internal medicine
Chiba, 261-0004
Tokuyama clinic
Chiba, 261-0004
Akaicho Clinic
Chiba-shi, Chiba, 260-0804
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
Naka Kinen Clinic
Ibaraki, 311-0113
Heiwadai Hospital_Internal Medicine
Miyazaki, Miyazaki, 880-0034
Heiwadai Hospital
Miyazaki, Miyazaki, 880-0034
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031
Fukuwa Clinic
Tokyo, 104-0031
Croatia10 sites
Opca bolnica Karlovac
Karlovac, 47000
Specijalna bolnica Krapinske Toplice - Endokrinologija
Krapinske Toplice, 49217
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice, 49217
Klinicki bolnicki centar Osijek_Endocrinology
Osijek, 31 000
Klinicki bolnicki centar Osijek
Osijek, 31 000
Clinical Hospital Centre Rijeka_Endocrinology
Rijeka, Primorje-Gorski Kotar County, 51 000
KBC Rijeka, Endokrinologija
Rijeka, Primorje-Gorski Kotar County, 51 000
Opca bolnica Varazdin_Endocrinology
Varaždin, 42 000
Opca bolnica Varazdin
Varaždin, 42 000
Poliklinika Solmed
Zagreb, City of Zagreb, 10000
Romania10 sites
Mariodiab Clinic SRL
Brasov, 500101
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucharest, 020475
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, 020475
Spitalul Clinic Judetean Urgenta Cluj-Napoca
Cluj-Napoca, Cluj, 400006
SC Grand Med SRL
Oradea, Bihor County, 410025
Grandmed SRL
Oradea, Bihor County, 410159
Novus Medical Clinica SRL
Ploieşti, Prahova, 100018
Sc Mediab Srl
Târgu Mureş, Mureș County, 540142
Cabinet Medical Dr Geru SRL
Timișoara, 300288
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Timișoara, 300723
Spain10 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Vithas Sevilla
Castilleja de la Cuesta, 41950
Hospital Gregorio Marañón
Madrid, 28007
Complejo Hospitalario de Pontevedra - Hospital de Montecelo
Pontevedra
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003
H. Infanta Luisa_Endocrino y Obesidad
Seville, 41010
Hospital Infanta Luisa
Seville, 41010
Hospital Nisa Sevilla Aljarafe
Seville, 41950
Greece9 sites
Iatriko Psychicou Private Clinic
Athens, 115 25
U.G.H of Athens "Attikon"
Athens, 12462
"Laiko" General Hospital of Athens
Goudi/Athens, 11527
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, 54645
424 Military General Training Hospital - 2nd Department of Internal Medicine
Thessaloniki, 564 29
424 Military General Training Hospital
Thessaloniki, 564 29
"Thermi" Private Hosital
Thessaloniki, 57001
EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
Thessaloniki, GR-54643
"Thermi" Private Hosital
Thessaloniki, GR-57001
Hungary9 sites
Bajcsy-Zsilinszky Kórház
Budapest, 1106
MH Egészségügyi Központ
Budapest, 1134
Debreceni Egyetem
Debrecen, Hajdú-Bihar, 4032
Debreceni Egyetem
Debrecen, 4031
Debreceni Egyetem
Debrecen, H-4031
Debreceni Egyetem
Debrecen, H-4032
Békés Megyei Központi Kórház
Gyula, 5700
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, 7400
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, H-7400
Germany7 sites
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910
Zentrum für klinische Studien Südbrandenburg GmbH
Elsterwerda, 04910
InnoDiab Forschung GmbH
Essen, 45136
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607
Wendisch/Dahl Hamburg
Hamburg, 22607
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758
Slovakia5 sites
DENTAVIA s.r.o.
Poprad, 05801
DIABETOL, s.r.o.
Prešov, 080 01
OLIVER - MED s.r.o.
Rimavská Sobota, 979 01
Peter Farkas MD, s.r.o.
Šahy, Slovak Republic, 93601
MEDIVASA, s.r.o., Diabetologicka ambulancia
Žilina, 010 01
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes (T2D)
- Being tested
- NNC0487-0111 subcutanous, Placebo (NNC0487-0111 subcutanous), NNC0487-0111 oral, Placebo (NNC0487-0111 oral)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111 subcutanousDrug
NNC0487-0111 administered subcutanously (under the skin)
Placebo (NNC0487-0111 subcutanous)Drug
NNC0487-0111 placebo administered subcutanously (under the skin)
NNC0487-0111 oralDrug
NNC0487-0111 administered orally (in the mouth)
Placebo (NNC0487-0111 oral)Drug
NNC0487-0111 placebo administered orally (in the mouth)
| Study group | Role | What they receive |
|---|---|---|
| Placebo subcutaneous | Placebo comparator | Placebo for subcutaneous treatment Receives: Drug: Placebo (NNC0487-0111 subcutanous) |
| NNC0487-0111 subcutaneous dose 1 | Experimental | NNC0487-0111 subcutaneous dose 1 treatment Receives: Drug: NNC0487-0111 subcutanous |
| NNC0487-0111 subcutaneous dose 2 | Experimental | NNC0487-0111 subcutaneous dose 2 treatment Receives: Drug: NNC0487-0111 subcutanous |
| NNC0487-0111 subcutaneous dose 3 | Experimental | NNC0487-0111 subcutaneous dose 3 treatment Receives: Drug: NNC0487-0111 subcutanous |
| NNC0487-0111 subcutaneous dose 4 | Experimental | NNC0487-0111 subcutaneous dose 4 treatment Receives: Drug: NNC0487-0111 subcutanous |
| NNC0487-0111 subcutaneous dose 5 | Experimental | NNC0487-0111 subcutaneous dose 5 treatment Receives: Drug: NNC0487-0111 subcutanous |
| NNC0487-0111 subcutaneous dose 6 | Experimental | NNC0487-0111 subcutaneous dose 6 treatment Receives: Drug: NNC0487-0111 subcutanous |
| Placebo oral | Placebo comparator | Placebo for oral treatment Receives: Drug: Placebo (NNC0487-0111 oral) |
| NNC0487-0111 oral dose 1 | Experimental | NNC0487-0111 oral dose 1 treatment Receives: Drug: NNC0487-0111 oral |
| NNC0487-0111 oral dose 2 | Experimental | NNC0487-0111 oral dose 2 treatment Receives: Drug: NNC0487-0111 oral |
| NNC0487-0111 oral dose 3 | Experimental | NNC0487-0111 oral dose 3 treatment Receives: Drug: NNC0487-0111 oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
percent point
Measured: From baseline (week 0) to end of treatment (week 36)
Secondary outcomes (17)
Relative change in body weight
percent
Measured: From baseline (week 0) to end of treatment (week 36)
Change in body weight
kg
Measured: From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
mmol/L
Measured: 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
Measured: From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)
kg/m^2
Measured: From baseline (week 0) to end of treatment (week 36)
Change in waist circumference
cm
Measured: From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)
mmHg
Measured: From baseline (week 0) to end of treatment (week 36)
Change in average 24-hour systolic blood pressure (SBP)
mmHg
Measured: From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive Protein (hsCRP)
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Change in triglycerides
Ratio to baseline
Measured: From baseline (week 0) to end of treatment (week 36)
Number of adverse events
Count of events
Measured: From baseline (week 0) to end of study (week 40)
Change in Urinary Albumin/Creatinine Ratio (UACR)
Ratio to baseline
Measured: 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
Measured: At end of treatment (week 36)
Change in eGFR creatinine- and cystatin C based CKD-EPI
mL/min/1.73 m^2
Measured: From baseline (week 0) to end of treatment (week 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start7 Aug 2024
- Primary completion1 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes (T2D)Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542874
- Sponsor's protocol ID
- NN9490-7678
- Other IDs
- U1111-1296-9708, 2023-509412-28, 2023
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Mora P, Aroda VR, Asong M, Bluher M, Heftdal LD, Carlander AF, Vilsen LN, Rosenstock J. Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial. Lancet. 2026 Jul 30:S0140-6736(26)01248-1. doi: 10.1016/S0140-6736(26)01248-1. Online ahead of print.
PubMed 42532080Mora P, Aroda VR, Asong M, Bluher M, Carlander AF, Kaltoft M, Vilsen LN, Rosenstock J. Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial. Lancet. 2026 Jul 30:S0140-6736(26)01247-X. doi: 10.1016/S0140-6736(26)01247-X. Online ahead of print.
PubMed 42532079
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study
- ClinicalTrials.gov ID
- NCT06542874
- Acronym / sponsor ID
- NN9490-7678
- Conditions
- Type 2 Diabetes (T2D)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Placebo subcutaneous | Placebo comparator | Drug: Placebo (NNC0487-0111 subcutanous)Placebo for subcutaneous treatment |
| NNC0487-0111 subcutaneous dose 1 | Experimental | Drug: NNC0487-0111 subcutanousNNC0487-0111 subcutaneous dose 1 treatment |
| NNC0487-0111 subcutaneous dose 2 | Experimental | Drug: NNC0487-0111 subcutanousNNC0487-0111 subcutaneous dose 2 treatment |
| NNC0487-0111 subcutaneous dose 3 | Experimental | Drug: NNC0487-0111 subcutanousNNC0487-0111 subcutaneous dose 3 treatment |
| NNC0487-0111 subcutaneous dose 4 | Experimental | Drug: NNC0487-0111 subcutanousNNC0487-0111 subcutaneous dose 4 treatment |
| NNC0487-0111 subcutaneous dose 5 | Experimental | Drug: NNC0487-0111 subcutanousNNC0487-0111 subcutaneous dose 5 treatment |
| NNC0487-0111 subcutaneous dose 6 | Experimental | Drug: NNC0487-0111 subcutanousNNC0487-0111 subcutaneous dose 6 treatment |
| Placebo oral | Placebo comparator | Drug: Placebo (NNC0487-0111 oral)Placebo for oral treatment |
| NNC0487-0111 oral dose 1 | Experimental | Drug: NNC0487-0111 oralNNC0487-0111 oral dose 1 treatment |
| NNC0487-0111 oral dose 2 | Experimental | Drug: NNC0487-0111 oralNNC0487-0111 oral dose 2 treatment |
| NNC0487-0111 oral dose 3 | Experimental | Drug: NNC0487-0111 oralNNC0487-0111 oral dose 3 treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0487-0111 subcutanousNNC0487-0111 administered subcutanously (under the skin) | Drug | NNC0487-0111 subcutaneous dose 1, NNC0487-0111 subcutaneous dose 2, NNC0487-0111 subcutaneous dose 3, NNC0487-0111 subcutaneous dose 4, NNC0487-0111 subcutaneous dose 5, NNC0487-0111 subcutaneous dose 6 |
| Placebo (NNC0487-0111 subcutanous)NNC0487-0111 placebo administered subcutanously (under the skin) | Drug | Placebo subcutaneous |
| NNC0487-0111 oralNNC0487-0111 administered orally (in the mouth) | Drug | NNC0487-0111 oral dose 1, NNC0487-0111 oral dose 2, NNC0487-0111 oral dose 3 |
| Placebo (NNC0487-0111 oral)NNC0487-0111 placebo administered orally (in the mouth) | Drug | Placebo oral |
Primary outcome
Change in HbA1c
Time frame: From baseline (week 0) to end of treatment (week 36)
percent point
17 secondary outcomes
Relative change in body weight
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body weight
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
Time frame: 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)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body mass index (BMI)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in waist circumference
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in average 24-hour systolic blood pressure (SBP)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive Protein (hsCRP)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in triglycerides
Time frame: From baseline (week 0) to end of treatment (week 36)
Number of adverse events
Time frame: From baseline (week 0) to end of study (week 40)
Change in Urinary Albumin/Creatinine Ratio (UACR)
Time frame: 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)
Time frame: At end of treatment (week 36)
Change in eGFR creatinine- and cystatin C based CKD-EPI
Time frame: From baseline (week 0) to end of treatment (week 36)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 42532080Mora P, Aroda VR, Asong M, Bluher M, Heftdal LD, Carlander AF, Vilsen LN, Rosenstock J. Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial. Lancet. 2026 Jul 30:S0140-6736(26)01248-1. doi: 10.1016/S0140-6736(26)01248-1. Online ahead of print.
- Derived from this study: PubMed 42532079Mora P, Aroda VR, Asong M, Bluher M, Carlander AF, Kaltoft M, Vilsen LN, Rosenstock J. Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial. Lancet. 2026 Jul 30:S0140-6736(26)01247-X. doi: 10.1016/S0140-6736(26)01247-X. Online ahead of print.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
137 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0487-0111 subcutanous and NNC0487-0111 oral in people with Type 2 Diabetes (T2D), run by Novo Nordisk A/S at 137 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 137 sites in United States, Poland, Bulgaria, Japan, Croatia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: From baseline (week 0) to end of treatment (week 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542874, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.