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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will look into a new study medicine called NNC0519-0130 to improve the treatment option for people living with excess body weight or type 2 diabetes or both. The purpose of this study is to compare the amount of NNC0519-0130 in the blood of participants who have excess body weight. The study comprises two parts and the participants will receive both preparations NNC0519-0130 B and NNC0519-0130 C, which treatment the participants get is decided by chance. The study will last for about 24 weeks.

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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