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Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

355 Participants Needed

NNC0519-0130 for Obesity

Recruiting at 47 trial locations

Overseen ByNovo Nordisk

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must not be taking: Obesity medications

Disqualifiers: Diabetes, HbA1c ≥ 6.5%, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 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 42 weeks.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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.

Inclusion Criteria

History of at least one self-reported unsuccessful dietary effort to lose body weight

I am either a male or a female who cannot become pregnant.

My BMI is 27 or higher and I have a weight-related health issue like high blood pressure.

See 2 more

Exclusion Criteria

I have a history of diabetes (type 1 or 2).

HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening

I haven't taken any obesity or weight management drugs in the last 90 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NNC0519-0130 or placebo injections once weekly for weight loss

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Treatment Details

Interventions

NNC0519-0130

Trial Overview 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.

Participant Groups

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