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

Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Type 2 Diabetes - a Dose Finding Study

Phase 2 Interventional Novo Nordisk A/S · NCT06326047

This study is testing different doses of a new medication to see how well it can lower blood sugar and help with weight loss in people with type 2 diabetes.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment288 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations116 sites (Chula Vista, California and 115 other locations)
Trial IDNCT06326047 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with a diagnosis of type 2 diabetes and specific HbA1c levels.

Not a fit: Patients with type 2 diabetes who do not meet the inclusion criteria or have contraindications to the study medication may not benefit.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for better management of blood sugar levels in patients with type 2 diabetes.

How similar studies have performed: Previous studies have shown promise with similar medications for type 2 diabetes, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Chula Vista, California and 115 other locations

+66 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.