Apply to Trial

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

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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