A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.

Key facts

Study ID

NCT06326047

Run by

Novo Nordisk A/S

People needed

299

Starts

2024-03-18

Expected to finish

2025-10-13

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female of non-childbearing potential, or male.
• For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male.
• Age 18-75 years (both inclusive) at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.
• Stable daily dose(s) more than or equal 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 sodium-glucose co-transporter 2 (SGLT2) inhibitor.
• Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
• Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m\^2).

You may not qualify if…

• 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.

Where it is running

• Valley Research — Fresno, California, United States
• 310 Clinical Research — Inglewood, California, United States
• Velocity Clin Res San Diego — La Mesa, California, United States
• First Valley Med Grp Lancaster — Lancaster, California, United States
• Torrance Clin Res Inst, Inc. — Lomita, California, United States
• Pacific Clinical Studies — Los Alamitos, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Med Partners, Inc. — Toluca Lake, California, United States
• UCLA Health Southbay Endocrine — Torrance, California, United States
• University Clin Investigators — Tustin, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Innovative Research of W Florida Inc. — Clearwater, Florida, United States
• Innovative Research of W FL — Clearwater, Florida, United States
• International Research Associates, LLC_Miami — Miami, Florida, United States
• Centricity Research — Columbus, Georgia, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Methodist Medical Center of Illinois — Peoria, Illinois, United States
• Centennial Medical Group — Columbia, Maryland, United States
• MD Medical Research — Oxon Hill, Maryland, United States
• Endo And Metab Cons — Rockville, Maryland, United States
• Clinvest Research — Springfield, Missouri, United States
• Mercury Str Med Grp, PLLC — Butte, Montana, United States
• Excel Clinical Network — Las Vegas, Nevada, United States
• Velocity Clin Res-Chula Vista — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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