← Back to Search

Other

NNC0519-0130 for Obesity

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 0) to end of treatment (week 40)
Awards & highlights

Summary

This trial will investigate the effectiveness of a new medication, NNC0519-0130, in helping people with excess body weight to lose weight. Participants will receive 1-2 injections of the

Who is the study for?
This trial is for individuals with obesity looking to lose weight. Participants will be given up to 6 different doses of a new medicine, NNC0519-0130, or a placebo. The medication is administered via weekly injections under the skin.Check my eligibility
What is being tested?
The study tests the effectiveness of various doses of NNC0519-0130 in helping people lose excess body weight compared to a placebo. It involves weekly subcutaneous injections over approximately 42 weeks.See study design
What are the potential side effects?
Potential side effects are not specified here but may include reactions at the injection site, gastrointestinal issues, and other common drug-related adverse events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to end of treatment (week 40)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to end of treatment (week 40) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative change in body weight
Secondary outcome measures
Achievement of greater than equal to (≥) 5% weight reduction
Achievement of ≥ 10% weight reduction
Achievement of ≥ 15% weight reduction
+17 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

Trial Design

13Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Dosing scheme f: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Group II: Dosing scheme e: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Group III: Dosing scheme d: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
Group IV: Dosing scheme c: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
Group V: Dosing scheme b: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
Group VI: Dosing scheme a: NNC0519-0130Experimental Treatment1 Intervention
Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
Group VII: Dosing scheme g: TirzepatideActive Control1 Intervention
Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Group VIII: Dosing scheme d: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group IX: Dosing scheme a: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group X: Dosing scheme e: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group XI: Dosing scheme b: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group XII: Dosing scheme f: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Group XIII: Dosing scheme c: PlaceboPlacebo Group1 Intervention
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
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
2,419,393 Total Patients Enrolled
144 Trials studying Obesity
132,143 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
111 Previous Clinical Trials
140,226 Total Patients Enrolled
30 Trials studying Obesity
49,513 Patients Enrolled for Obesity
~171 spots leftby Nov 2024