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

NCT06326047

CompletedPhase 2

Sponsor: Novo Nordisk A/S

Conditions: Diabetes Mellitus, Type 2

Interventions: NNC0519-0130, Placebo, Trizepatide

Countries: United States, Australia, Canada, India, Japan, South Africa, South Korea

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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).

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. 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.

Locations (110)

Chula Vista, California, United States
Fresno, California, United States
Inglewood, California, United States
La Mesa, California, United States
Lancaster, California, United States
Lomita, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Montclair, California, United States
San Diego, California, United States
Toluca Lake, California, United States
Torrance, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Aurora, Colorado, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Miami, Florida, United States
Columbus, Georgia, United States
Blackfoot, Idaho, United States
Peoria, Illinois, United States
Iowa City, Iowa, United States
Columbia, Maryland, United States
Oxon Hill, Maryland, United States
Rockville, Maryland, United States
Springfield, Missouri, United States
Butte, Montana, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
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