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Albion Finch Medical Centre | Clinical Practice of Family Medicine

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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

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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

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

Trial contacts and locations

81

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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