Different doses of NNC0662-0419 versus semaglutide and placebo to lower blood sugar in adults with type 2 diabetes
Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study
This trial will test whether different doses of the experimental medicine NNC0662-0419 lower blood sugar in adults with type 2 diabetes compared with placebo or semaglutide.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 63 sites (Lancaster, California and 62 other locations) |
| Trial ID | NCT07415954 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized trial gives participants either NNC0662-0419 at varying doses, semaglutide, or placebo, with assignment decided by chance. The study measures blood sugar control (HbA1c) and safety outcomes over the treatment period. NNC0662-0419 is a new medicine that has been previously tested in humans but is not yet approved, while semaglutide is an approved diabetes medication used here as an active comparator. The goal is to identify effective and tolerable dosing for NNC0662-0419 in adults with type 2 diabetes.
Who should consider this trial
Good fit: Adults aged 18–75 with type 2 diabetes and an HbA1c of 7.0–10.0% who are willing to pursue substantial weight loss (>25% of baseline weight) and meet other eligibility criteria may qualify.
Not a fit: People with uncontrolled or unstable diabetic retinopathy/maculopathy, known hypoglycaemic unawareness, recent treatment with other diabetes or obesity medications, or who cannot meet the weight-loss requirement are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, NNC0662-0419 could provide an additional option to lower blood sugar for people with type 2 diabetes, potentially with a different dosing or side-effect profile than current medicines.
How similar studies have performed: Approved drugs in the same class as semaglutide have reliably lowered blood sugar and body weight, but NNC0662-0419 is a novel compound with limited published efficacy data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * 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). 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. 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.
Where this trial is running
Lancaster, California and 62 other locations
- First Valley Medical Group — Lancaster, California, United States (Recruiting)
- Torrance Clinical Research Institute, Inc. — Lomita, California, United States (Recruiting)
- Ark Clinical Research — Long Beach, California, United States (Recruiting)
- Pacific Clinical Studies — Los Alamitos, California, United States (Recruiting)
- Wetlin Research Associates, Inc. — San Diego, California, United States (Recruiting)
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States (Recruiting)
- Encore Medical Research LLC — Hollywood, Florida, United States (Recruiting)
- Bioclinical Research Alliance — Miami, Florida, United States (Recruiting)
- South Broward Research LLC — Miramar, Florida, United States (Recruiting)
- West Orange Endocrinology — Ocoee, Florida, United States (Not_yet_recruiting)
- Encore Medical Research of Weston — Weston, Florida, United States (Recruiting)
- Elite Clinical Trials — Blackfoot, Idaho, United States (Recruiting)
- Cedar-Crosse Research Center — Chicago, Illinois, United States (Recruiting)
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Headlands Research — Springfield, Missouri, United States (Recruiting)
- PharmQuest — Greensboro, North Carolina, United States (Recruiting)
- Piedmont Healthcare Statesville — Statesville, North Carolina, United States (Recruiting)
- Providence Center for Clinical Research — Dayton, Ohio, United States (Recruiting)
- CNS Healthcare — Memphis, Tennessee, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- JCCT- Juno NW Houston — Houston, Texas, United States (Recruiting)
- Consano Clinical Research, LLC — Shavano Park, Texas, United States (Recruiting)
- Frontier Clinical Research - Kingwood — Kingwood, West Virginia, United States (Not_yet_recruiting)
- Opca bolnica Karlovac — Karlovac, Croatia (Not_yet_recruiting)
- Poliklinika SLAVONIJA OSIJEK — Osijek, Croatia (Recruiting)
- Opca bolnica Varazdin_Endocrinology — Varaždin, Croatia (Recruiting)
- Poliklinika Solmed — Zagreb, Croatia (Recruiting)
- Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ — Szeged, Csongrád-Csanád, Hungary (Not_yet_recruiting)
- Debreceni Egyetem — Debrecen, Hajdú-Bihar, Hungary (Not_yet_recruiting)
- Debreceni Egyetem — Debrecen, Hungary (Not_yet_recruiting)
- Akaicho Clinic_Diabetes Internal Medicine — Chiba-shi, Chiba, Japan (Recruiting)
- Naka Kinen Clinic_Internal medicine — Ibaraki, Japan (Recruiting)
- Soka Sugiura Internal Medicine Clinic — Soka-shi, Saitama, Japan (Recruiting)
- Tokyo-Eki Center-building Clinic_Internal Medicine — Tokyo, Japan (Recruiting)
- ToCROM Clinic_Internal Medicine — Tokyo, Japan (Recruiting)
- "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik — Bialystok, Podlaskie Voivodeship, Poland (Not_yet_recruiting)
- Terpa Sp. z o.o. Sp. k. — Lublin, Poland (Not_yet_recruiting)
- Formed 2 Sp. z o.o. — Oświęcim, Poland (Recruiting)
- PANSTWOWY INSTYTUT MEDYCZNY MSWiA — Warsaw, Poland (Recruiting)
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko — Zabrze, Poland (Recruiting)
- Sanfil-Casa De Saude De Santa Filomena S.A. — Coimbra, Portugal (Recruiting)
- Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda — Ponte de Lima, Portugal (Not_yet_recruiting)
- Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos — Vila do Conde, Portugal (Not_yet_recruiting)
- Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia — Vila Nova de Gaia, Portugal (Recruiting)
- DIADA, s.r.o. — Bardejov, Slovakia (Recruiting)
- Metabol KLINIK s.r.o. — Bratislava, Slovakia (Not_yet_recruiting)
- Diacrin s. r. o. — Bratislava, Slovakia (Recruiting)
- SIN AZUCAR s.r.o. — Malacky, Slovakia (Recruiting)
- Korea University Ansan Hospital_Endocrinology — Ansan-si, Gyeonggi-do, South Korea (Not_yet_recruiting)
- Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (Not_yet_recruiting)
+13 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.