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

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: NNC0519-0130; Drug: Placebo; Drug: Trizepatide

• Registration Number: NCT06326047
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-16
• Study Start: 2024-03-18
• Study First Posted: 2024-03-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-09-15
• Study Completion: 2025-10-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Glycated haemoglobin (HbA1c)	From baseline (week 0) to 12 weeks on a given maintenance dose	Measured as percentage point (%-point)

Secondary Outcome Measures

Name	Time	Method
Change in Glycated haemoglobin (HbA1c)	From baseline (week 0) to end of treatment (week 36)	Measured as percentage point (%-point)
Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))	From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively	Measured as percentage point (%-point)
Change in high sensitivity C-Reactive Protein (hsCRP)	From baseline (week 0) to end of treatment (week 36)	Measured as ratio to baseline
Relative change in body weight	From baseline (week 0) to end of treatment (week 36)	Measured as percentage (%)
Change in body weight	From baseline (week 0) to end of treatment (week 36)	Measured as kilograms (kg)
Change in fasting plasma glucose (FPG)	From baseline (week 0) to 12 weeks on a given maintenance dose	Measured as millimoles per liter (mmol/L)
Change in waist circumference	From baseline (week 0) to end of treatment (week 36)	Measured as centimeter (cm)
Change in systolic blood pressure (SBP)	From baseline (week 0) to end of treatment (week 36)	Measured as millimeters of mercury (mmHg)
Change in total cholesterol	From baseline (week 0) to end of treatment (week 36)	Measured as ratio to baseline
Change in high-density lipoprotein (HDL) cholesterol	From baseline (week 0) to end of treatment (week 36)	Measured as ratio to baseline
Change in low-density lipoprotein (LDL) cholesterol	From baseline (week 0) to end of treatment (week 36)	Measured as ratio to baseline
Change in triglycerides	From baseline (week 0) to end of treatment (week 36)	Measured as ratio to baseline
Number of adverse events	From baseline (week 0) to end of study (week 40)	Measured as number of events

Trial Locations

Locations (92)

Velocity Clin Res-Chula Vista; 🇺🇸 Chula Vista, California, United States

Valley Research; 🇺🇸 Fresno, California, United States

310 Clinical Research; 🇺🇸 Inglewood, California, United States

Velocity Clin Res San Diego; 🇺🇸 La Mesa, California, United States

First Valley Med Grp Lancaster; 🇺🇸 Lancaster, California, United States

Torrance Clin Res Inst, Inc.; 🇺🇸 Lomita, California, United States

Pacific Clinical Studies; 🇺🇸 Los Alamitos, California, United States

Catalina Research Institute, LLC; 🇺🇸 Montclair, California, United States

Med Partners, Inc.; 🇺🇸 Toluca Lake, California, United States

UCLA Health Southbay Endocrine; 🇺🇸 Torrance, California, United States

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