Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Keywords

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 2 Diabetes Mellitus, NNC0519-0130, Trizepatide, Dosing scheme A (NNC0519-0130), Dosing scheme B (NNC0519-0130), Dosing scheme C (NNC0519-0130), Dosing scheme D (NNC0519-0130), Dosing scheme E (NNC0519-0130), Dosing scheme F (tirzepatide)

Eligibility

You can join if…

Open to people ages 18-75

  • 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/m2).

You CAN'T join 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.

Locations

  • UCLA Health Southbay Endocrine not yet accepting patients
    Torrance California 90505 United States
  • University Clin Investigators accepting new patients
    Tustin California 92780 United States
  • Valley Research not yet accepting patients
    Fresno California 93720 United States
  • Valley Research withdrawn
    Fresno California 93720 United States
  • Med Partners, Inc. accepting new patients
    Toluca Lake California 91602 United States
  • Velocity Clin Res San Diego accepting new patients
    La Mesa California 91942 United States
  • Pacific Clinical Studies accepting new patients
    Los Alamitos California 90720 United States
  • Torrance Clin Res Inst, Inc. accepting new patients
    Lomita California 90717 United States
  • Velocity Clin Res-Chula Vista accepting new patients
    Chula Vista California 91911 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Novo Nordisk A/S
ID
NCT06326047
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 288 study participants
Last Updated