Diabetes Mellitus, Type 2Phase 2NCT07415954
A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes
A Phase 2 study testing NNC0662-0419 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 63 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- NNC0662-0419 and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 63 sitesin 10 countries
- Study dates
- 17 Apr 2026to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 (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).
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. 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.
Trial locations and contacts
63 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
63 sites in 10 countries
United States23 sites, 23 recruiting
- Recruiting
Elite Clinical Trials
Blackfoot, Idaho, 83221
- Not yet recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115-5804
- Recruiting
Cedar-Crosse Research Center
Chicago, Illinois, 60607
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9302
- Recruiting
Providence Center for Clinical Research
Dayton, Ohio, 45439
- Recruiting
PharmQuest
Greensboro, North Carolina, 27408
- Recruiting
Encore Medical Research LLC
Hollywood, Florida, 33024
- Recruiting
JCCT- Juno NW Houston
Houston, Texas, 77040
- Not yet recruiting
Frontier Clinical Research - Kingwood
Kingwood, West Virginia, 26537
- Recruiting
First Valley Medical Group
Lancaster, California, 93534
- Recruiting
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717
- Recruiting
Ark Clinical Research
Long Beach, California, 90815
- Recruiting
Pacific Clinical Studies
Los Alamitos, California, 90720
- Recruiting
CNS Healthcare
Memphis, Tennessee, 38119
- Recruiting
Bioclinical Research Alliance
Miami, Florida, 33155
- Recruiting
South Broward Research LLC
Miramar, Florida, 33027
- Not yet recruiting
West Orange Endocrinology
Ocoee, Florida, 34761
- Recruiting
Wetlin Research Associates, Inc.
San Diego, California, 92120
- Recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
- Recruiting
Headlands Research
Springfield, Missouri, 65807
- Recruiting
Piedmont Healthcare Statesville
Statesville, North Carolina, 28625
- Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
- Recruiting
Encore Medical Research of Weston
Weston, Florida, 33331
Spain6 sites, 6 recruiting
- Not yet recruiting
Centro de Salud A Estrada
A Estrada, 36680
- Recruiting
Equip D´Atencio Primaria Barcelona Sardenya
Barcelona, 08025
- Recruiting
Hospital Vithas Sevilla
Castilleja de la Cuesta, 41950
- Recruiting
Clínica Bofill
Girona, 17002
- Recruiting
ABS La Roca CAP Vicenç_Endocrino
La Roca Del Vallés, Barcelona, 08430
- Recruiting
Centro de Saúde Concepción Arenal
Santiago de Compostela, 15701
Japan5 sites
- Active, not recruiting
Akaicho Clinic_Internal medicine
Chiba-shi, Chiba, 260-0804
- Active, not recruiting
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
- Active, not recruiting
Soka Sugiura Internal Medicine Clinic
Soka-shi, Saitama, 340-0015
- Active, not recruiting
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027
- Active, not recruiting
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008
Poland5 sites, 5 recruiting
- Recruiting
"Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351
- Not yet recruiting
Terpa Sp. z o.o. Sp. k.
Lublin, 20-333
- Recruiting
Formed 2 Sp. z o.o.
Oświęcim, 32-600
- Recruiting
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
Warsaw, 02-507
- Recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, 41-800
Thailand5 sites, 5 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
- Recruiting
Siriraj Hospital
Bangkok, 10700
- Recruiting
Maharaj Nakorn Chiang Mai
Chiang Mai, 50200
- Recruiting
Srinagarind Hospital
Khon Kaen, 40002
- Recruiting
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima, 30000
Croatia4 sites, 4 recruiting
- Recruiting
Opca bolnica Karlovac
Karlovac, 47000
- Recruiting
Poliklinika SLAVONIJA OSIJEK
Osijek, 31000
- Recruiting
Opca bolnica Varazdin_Endocrinology
Varaždin, 42 000
- Recruiting
Poliklinika Solmed
Zagreb, 10000
Portugal4 sites, 4 recruiting
- Recruiting
Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos
Coimbra, 3000-150
- Recruiting
Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda
Ponte de Lima, 4990-029
- Recruiting
Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos
Vila do Conde, 4480-565
- Recruiting
Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia
Vila Nova de Gaia, 4400-346
Slovakia4 sites, 4 recruiting
- Recruiting
DIADA, s.r.o.
Bardejov, 08501
- Recruiting
Metabol KLINIK s.r.o.
Bratislava, 811 08
- Recruiting
Diacrin s. r. o.
Bratislava, 83101
- Recruiting
SIN AZUCAR s.r.o.
Malacky, 901 01
South Korea4 sites, 4 recruiting
- Recruiting
Korea University Ansan Hospital_Endocrinology
Ansan-si, Gyeonggi-do, 15355
- Recruiting
Nowon Eulji Medical Center, Eulji University_Endocrinology
Seoul, 01830
- Recruiting
Kangbuk Samsung Hospital_Endocrinology
Seoul, 03181
- Recruiting
Pusan National University Yangsan Hospital_Family Medicine
Yangsan, Gyeongsangnam-do, 50612
Hungary3 sites, 3 recruiting
- Not yet recruiting
Debreceni Egyetem
Debrecen, Hajdú-Bihar, 4032
- Not yet recruiting
Debreceni Egyetem
Debrecen, 4031
- Not yet recruiting
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, 6725
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- NNC0662-0419, Semaglutide, Placebo
- 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.
NNC0662-0419Drug
NNC0662-0419 will be administered subcutaneously.
SemaglutideDrug
Semaglutide will be administered subcutaneously.
PlaceboDrug
Placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| NNC0662-0419 | Experimental | Participants will receive NNC0662-0419 subcutaneously (s.c.) in a dose escalating manner once weekly. Receives: Drug: NNC0662-0419 |
| Semaglutide | Active comparator | Participants will receive semaglutide s.c. once weekly. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive placebo matched to their respective investigational medicinal product s.c. once weekly. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated haemoglobin (HbA1c) (week 16)
Measured as percentage-point (%-point).
Measured: From baseline (week 0) to week 16
Change in HbA1c (week 28)
Measured as %-point.
Measured: From baseline (week 0) to week 28
Change in HbA1c (week 40)
Measured as %-point.
Measured: From baseline (week 0) to week 40
Secondary outcomes (14)
Relative change in body weight
Measured as percentage (%).
Measured: From baseline (week 0) to (week 40)
Change in body weight
Measured as kilogram (kg).
Measured: From baseline (week 0) to (week 40)
Change in HbA1c
Measured as %-point.
Measured: From baseline (week 0) to (week 16, 28 and 40)
Change in Fasting Plasma Glucose (FPG)
Measured as millimoles per litre (mmol/L).
Measured: From baseline (week 0) to (week 16, 28 and 40)
Change in Body Mass Index (BMI)
Measured in kilograms per square metre (kg/m^2).
Measured: From baseline (week 0) to (week 40)
Change in waist circumference
Measured in centimetre (cm).
Measured: From baseline (week 0) to (week 40)
Change in high sensitivity C-Reactive Protein (hsCRP)
Measured as ratio to baseline.
Measured: From baseline (week 0) to (week 40)
Change in total cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to (week 40)
Change in High-Density Lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to (week 40)
Change in Low-Density Lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to (week 40)
Change in triglycerides
Measured as ratio to baseline.
Measured: From baseline (week 0) to (week 40)
Change in Urine Albumin Creatinine Ratio (UACR)
Measured as ratio to baseline.
Measured: 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)
Measured in millilitres per minute per 1.73 square metre (mL/min/1.73 m^2).
Measured: From baseline (week 0) to (week 40)
Number of adverse events
Measured as number of events.
Measured: From baseline (week 0) to (week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start17 Apr 2026
- Primary completion3 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 270 participants (estimated)
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
- NCT07415954
- Sponsor's protocol ID
- NN9662-8160
- Other IDs
- U1111-1324-0310, 2025-523260-20, 2025
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2026
- Last updated
- 11 Sep 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study
- ClinicalTrials.gov ID
- NCT07415954
- Acronym / sponsor ID
- NN9662-8160
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 3 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Feb 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NNC0662-0419 | Experimental | Drug: NNC0662-0419Participants will receive NNC0662-0419 subcutaneously (s.c.) in a dose escalating manner once weekly. |
| Semaglutide | Active comparator | Drug: SemaglutideParticipants will receive semaglutide s.c. once weekly. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to their respective investigational medicinal product s.c. once weekly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
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. 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.
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 |
|---|---|---|
| NNC0662-0419NNC0662-0419 will be administered subcutaneously. | Drug | NNC0662-0419 |
| SemaglutideSemaglutide will be administered subcutaneously. | Drug | Semaglutide |
| PlaceboPlacebo will be administered subcutaneously. | Drug | Placebo |
Primary outcome
Change in glycated haemoglobin (HbA1c) (week 16)
Time frame: From baseline (week 0) to week 16
Measured as percentage-point (%-point).
Change in HbA1c (week 28)
Time frame: From baseline (week 0) to week 28
Measured as %-point.
Change in HbA1c (week 40)
Time frame: From baseline (week 0) to week 40
Measured as %-point.
14 secondary outcomes
Relative change in body weight
Time frame: From baseline (week 0) to (week 40)
Change in body weight
Time frame: From baseline (week 0) to (week 40)
Change in HbA1c
Time frame: 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)
Change in Body Mass Index (BMI)
Time frame: From baseline (week 0) to (week 40)
Change in waist circumference
Time frame: From baseline (week 0) to (week 40)
Change in high sensitivity C-Reactive Protein (hsCRP)
Time frame: From baseline (week 0) to (week 40)
Change in total cholesterol
Time frame: From baseline (week 0) to (week 40)
Change in High-Density Lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to (week 40)
Change in Low-Density Lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to (week 40)
Change in triglycerides
Time frame: 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)
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)
Number of adverse events
Time frame: From baseline (week 0) to (week 48)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
63 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NNC0662-0419 and Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 63 sites in 10 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 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Spain, Japan, Poland, Thailand and 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) (week 16) (time frame: From baseline (week 0) to week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.