NNC0519-0130 for Obesity

Overseen By Novo Nordisk

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must not be taking: Prescription drugs

Disqualifiers: Diabetes, Respiratory, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NNC0519-0130, a potential drug for obesity, to assist individuals who are overweight, have type 2 diabetes, or both. The goal is to determine how much of the treatment remains in the blood, potentially leading to better treatment options. Participants will receive two different versions of the treatment, and the trial lasts about 24 weeks. It may suit individuals who are overweight due to excess body fat and are not taking certain medications. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking most prescription and nonprescription medications, except for routine vitamins and occasional use of certain over-the-counter pain relievers, at least 14 days before the trial starts.

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

Research has shown that NNC0519-0130 has been studied for its safety. These studies have examined how the medicine works in the body and its possible side effects. Researchers have tested different ways to increase the dosage to see if it can reduce side effects. Another study examined the safety of various doses to understand how the medicine might help with kidney function.

Since the current trial for NNC0519-0130 is in its early stages, information on its safety in humans remains limited. Early trials typically aim to find the best dose and monitor for any side effects. While safety information is being gathered, a complete picture of how well the treatment is tolerated may not yet be available. Participants can expect close monitoring to ensure the treatment's safety during the trial. ^{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 novel approach compared to current treatments like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. Unlike these standard options, NNC0519-0130 employs a unique formulation that involves a pre-determined dose escalation regimen, which might optimize its effectiveness and safety profile. This innovative dosing strategy, combined with the potential for a new active ingredient, could offer a promising alternative for individuals struggling with obesity, potentially leading to improved outcomes and greater accessibility.

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

Studies have shown that NNC0519-0130 is being developed to assist individuals with excess body weight and type 2 diabetes. Research indicates that this treatment targets specific bodily processes to enhance metabolism and control blood sugar levels. Initial findings suggest that different formulations of NNC0519-0130, which participants in this trial will receive, might reduce side effects and enhance effectiveness. Researchers are also studying the treatment's potential to improve kidney function. Although data is still emerging, these early studies offer a promising outlook for its use in managing obesity and related conditions. ^{1 2 4 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 overweight or obesity. Participants will be involved in the study for about 24 weeks and will receive two different preparations of a new medication, NNC0519-0130, aimed at improving treatment options for excess body weight or type 2 diabetes.

Inclusion Criteria

Body Mass Index (BMI) between 27.0 kg/m^2 and 39.9 kg/m^2 at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

I cannot become pregnant or get someone pregnant.

Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria

Glycated hemoglobin (HbA1c) ≥ 6.5 % (48 mmol/mol) at screening

Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

I haven't taken any prescription or nonprescription drugs, except for vitamins or occasional pain relief, in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C

12 weeks

Treatment Part 2

Participants continue with a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NNC0519-0130

Trial Overview The study is testing how much of the medicine NNC0519-0130 ends up in the blood when given as two different preparations (NNC0519-0130 B and C). The participants are randomly chosen to receive each preparation to compare their effects on people with excess body weight.

How Is the Trial Designed?

Group I: Part 2b: NNC0519-0130 C and NNC0519-0130 B Experimental Treatment 2 Interventions

Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B.

Group II: Part 2a: NNC0519-0130 B and NNC0519-0130 C Experimental Treatment 2 Interventions

Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C.

Group III: Part 1b: NNC0519-0130 B and NNC0519-0130 C Experimental Treatment 2 Interventions

Participants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.

Group IV: Part 1a: NNC0519-0130 C and NNC0519-0130 B Experimental Treatment 2 Interventions

Participants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06567041

NCT06567041 | A Research Study of How Safe a New ... A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06717698

NCT06717698 | A Research Study Comparing How Well ... The study evaluates the safety of different doses of a new medicine called NNC0519 0130. It also looks into how the medicine may improve kidney function in ...

3. trial.medpath.com trial.medpath.com/clinical-trial/5c5fc4526dc31d85/nct06718998-nnc0519-0130-overweight-obesity

A Research Study Comparing Different Ways of Increasing the ... Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and ...

4. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9541-7760.html

A Research Study Comparing Different Ways of Increasing ... The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects ...

5. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=22335&isClinicalTrial=True

ANZCTR - Registration Experimental: Dosing scheme c: NNC0519-0130 - Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks. Placebo ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/560035

A Research Study Comparing Different Ways of Increasing ... The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects ...

7. ctv.veeva.com ctv.veeva.com/study/a-research-study-of-a-new-medicine-nnc0519-0130-in-healthy-people-people-with-high-body-weight-and

A Research Study of a New Medicine NNC0519-0130 in ... This study will be looking into how safe the new medicine NNC0519-0130 is and will measure its concentrations in the blood. Moreover, effects on ...