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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

Purpose

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.

Condition

Diabetes Mellitus, Type 2

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Dosing scheme A (NNC0519-0130)	Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.	Drug: NNC0519-0130 NNC0519-0130 will be administered subcutaneously.
Placebo Comparator Dosing scheme A (Placebo)	Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo Placebo will be administered subcutaneously.
Experimental Dosing scheme B (NNC0519-0130)	Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.	Drug: NNC0519-0130 NNC0519-0130 will be administered subcutaneously.
Placebo Comparator Dosing scheme B (Placebo)	Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo Placebo will be administered subcutaneously.
Experimental Dosing scheme C (NNC0519-0130)	Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.	Drug: NNC0519-0130 NNC0519-0130 will be administered subcutaneously.
Placebo Comparator Dosing scheme C (Placebo)	Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo Placebo will be administered subcutaneously.
Experimental Dosing scheme D (NNC0519-0130)	Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.	Drug: NNC0519-0130 NNC0519-0130 will be administered subcutaneously.
Placebo Comparator Dosing scheme D (Placebo)	Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo Placebo will be administered subcutaneously.
Experimental Dosing scheme E (NNC0519-0130)	Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.	Drug: NNC0519-0130 NNC0519-0130 will be administered subcutaneously.
Placebo Comparator Dosing scheme E (Placebo)	Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo Placebo will be administered subcutaneously.
Active Comparator Dosing scheme F (tirzepatide)	Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.	Drug: Trizepatide Trizepatide will be administered subcutaneously.

Recruiting Locations

Torrance Clin Res Inst, Inc.
Lomita, California 90717

Pacific Clinical Studies
Los Alamitos, California 90720

Catalina Research Institute, LLC
Montclair, California 91763

Innovative Research of W Florida Inc.
Clearwater, Florida 33756

International Research Associates, LLC_Miami
Miami, Florida 33183

MD Medical Research
Oxon Hill, Maryland 20745

Velocity Clin Res_Cincinnati
Cincinnati, Ohio 45242

Velocity Clinical Research Springdale
Cincinnati, Ohio 45246

More Details

NCT ID: NCT06326047
Status: Recruiting
Sponsor: Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.