Comparing different doses of NN0519-0130 for lowering blood sugar in type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a new medication, NN0519-0130, in reducing blood sugar levels and body weight in individuals with type 2 diabetes. Participants will receive one of seven different doses of the medication, administered via weekly injections for approximately 40 weeks. The assignment of treatment will be randomized, ensuring a robust comparison between the active medication and placebo. The study aims to determine the optimal dosing for maximum efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Torrance Clin Res Inst, Inc.
  Lomita, California, United States Recruiting
• Pacific Clinical Studies
  Los Alamitos, California, United States Recruiting
• Catalina Research Institute, LLC
  Montclair, California, United States Recruiting
• Innovative Research of W Florida Inc.
  Clearwater, Florida, United States Recruiting
• International Research Associates, LLC_Miami
  Miami, Florida, United States Recruiting
• MD Medical Research
  Oxon Hill, Maryland, United States Recruiting

+66 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.