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Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

NNC0519-0130 for Obesity

No longer recruiting at 54 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 trial aims to test a new medicine, NNC0519-0130, to help individuals with excess body weight lose weight. Participants will receive weekly injections of NNC0519-0130 at varying doses to determine the most effective one, while some will receive a placebo or a comparison drug called tirzepatide. The trial seeks individuals who have unsuccessfully tried to lose weight through diet and have a BMI of 27 or higher, possibly with a related condition like high blood pressure. Participants will be involved for about 42 weeks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important weight loss research.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication prescribed for obesity or weight management at least 90 days before joining. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that NNC0519-0130 was tested for safety in earlier studies. Researchers tried different doses to observe the body's response. Although detailed information on side effects remains unavailable, this phase of testing suggests the treatment is generally safe for further research.

For the other treatment in the trial, tirzepatide, studies have found it can cause common side effects such as nausea, diarrhea, and vomiting. Despite these side effects, tirzepatide has already received approval for some conditions, indicating it is considered safe.

Overall, both NNC0519-0130 and tirzepatide have undergone study, and current evidence suggests they are safe enough for further testing. However, as with any treatment, individual experiences may vary.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about NNC0519-0130 for obesity because it represents a potentially groundbreaking approach in this field. Unlike current treatments, such as lifestyle interventions and medications like orlistat or GLP-1 receptor agonists, NNC0519-0130 is designed to be administered subcutaneously once a week, which may enhance patient compliance. This treatment is being investigated at multiple dosing levels, indicating a tailored approach that could optimize effectiveness and minimize side effects. Moreover, the inclusion of an active comparator, tirzepatide, suggests that researchers are keen to evaluate its efficacy against one of the promising newer therapies, highlighting the potential of NNC0519-0130 to offer a novel mechanism or enhanced benefits in managing obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that tirzepatide, tested in one of the treatment arms of this trial, is highly effective for weight loss. In a 72-week study, participants lost a significant amount of weight with weekly doses of 5 mg, 10 mg, or 15 mg. Many lost more than 20% of their body weight compared to those who received a placebo, a substance with no active drug. For NNC0519-0130, another treatment under study in this trial, current information focuses on its safety and dosage. Early studies are exploring its potential for weight loss, but detailed results are not yet available.¹ ³ ⁵ ⁶ ⁷

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.

BMI ≥ 30.0 kg/m2

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?

Treatment 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