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

Description

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.

Conditions

Diabetes Mellitus, Type 2

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Diabetes Mellitus, Type 2
Intervention / Treatment

-

Contacts and Locations

Chula Vista

Velocity Clin Res-Chula Vista, Chula Vista, California, United States, 91911

Fresno

Valley Research, Fresno, California, United States, 93720

Fresno

Valley Research, Fresno, California, United States, 93720

Inglewood

310 Clinical Research, Inglewood, California, United States, 90301

La Mesa

Velocity Clin Res San Diego, La Mesa, California, United States, 91942

Lancaster

First Valley Med Grp Lancaster, Lancaster, California, United States, 93534

Lomita

Torrance Clin Res Inst, Inc., Lomita, California, United States, 90717

Los Alamitos

Pacific Clinical Studies, Los Alamitos, California, United States, 90720

Montclair

Catalina Research Institute, LLC, Montclair, California, United States, 91763

Toluca Lake

Med Partners, Inc., Toluca Lake, California, United States, 91602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2025-10-13