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NNC0519-0130 for Obesity

Phase 2

Waitlist Available

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)

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to end of treatment (week 40)

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

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

Primary study objectives

Relative change in body weight

Secondary study objectives

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%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

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