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

Novo Nordisk

Status and phase: Enrolling; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Trizepatide; Drug: NNC0519-0130; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06326047

jRCT2031230704 (Registry Identifier)

NN9541-4945

U1111-1291-9196 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 11 patient groups, including a placebo group

Dosing scheme A (NNC0519-0130)

Experimental group

Description:

Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.

Treatment:

Drug: NNC0519-0130

Dosing scheme A (Placebo)

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Treatment:

Drug: Placebo

Dosing scheme B (NNC0519-0130)

Experimental group

Description:

Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.

Treatment:

Drug: NNC0519-0130

Dosing scheme B (Placebo)

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Treatment:

Drug: Placebo

Dosing scheme C (NNC0519-0130)

Experimental group

Description:

Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Treatment:

Drug: NNC0519-0130

Dosing scheme C (Placebo)

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Treatment:

Drug: Placebo

Dosing scheme D (NNC0519-0130)

Experimental group

Description:

Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Treatment:

Drug: NNC0519-0130

Dosing scheme D (Placebo)

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Treatment:

Drug: Placebo

Dosing scheme E (NNC0519-0130)

Experimental group

Description:

Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.

Treatment:

Drug: NNC0519-0130

Dosing scheme E (Placebo)

Placebo Comparator group

Description:

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Treatment:

Drug: Placebo

Dosing scheme F (tirzepatide)

Active Comparator group

Description:

Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.

Treatment:

Drug: Trizepatide