NNC0519-0130 for Type 2 Diabetes

Phase 2

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively

Awards & highlights

Summary

This trial will test a new medicine called NNC0519-0130 to see how well it can help people with type 2 diabetes lower their blood sugar and body weight. Participants will receive

Who is the study for?

This trial is for individuals with type 2 diabetes interested in testing a new medication, NNC0519-0130, which may help lower blood sugar and body weight. Participants will be randomly assigned to receive one of up to seven different doses or a placebo through weekly injections for about 40 weeks.

What is being tested?

The study is testing the effectiveness of various doses of a new drug called NNC0519-0130 compared to a placebo in lowering blood sugar levels in people with type 2 diabetes. The medicine is administered via subcutaneous injections.

What are the potential side effects?

Potential side effects are not specified here but generally could include reactions at the injection site, low blood sugar (hypoglycemia), nausea, fatigue, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Glycated haemoglobin (HbA1c)

Change in body weight

Change in fasting plasma glucose (FPG)

+10 more

Trial Design

11Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Dosing scheme E (NNC0519-0130)Experimental Treatment1 Intervention

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

Group II: Dosing scheme D (NNC0519-0130)Experimental Treatment1 Intervention

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

Group III: Dosing scheme C (NNC0519-0130)Experimental Treatment1 Intervention

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

Group IV: Dosing scheme B (NNC0519-0130)Experimental Treatment1 Intervention

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

Group V: Dosing scheme A (NNC0519-0130)Experimental Treatment1 Intervention

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

Group VI: Dosing scheme F (tirzepatide)Active Control1 Intervention

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

Group VII: Dosing scheme A (Placebo)Placebo Group1 Intervention