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Anti-diabetic agent

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group VIII: Dosing scheme B (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group IX: Dosing scheme C (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group X: Dosing scheme D (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Group XI: Dosing scheme E (Placebo)Placebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0519-0130
2023
Completed Phase 1
~190

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,525 Previous Clinical Trials
2,419,448 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
111 Previous Clinical Trials
140,281 Total Patients Enrolled
~144 spots leftby Nov 2024