NNC0662-0419 for Obesity

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Must be taking: Birth control pills

Must not be taking: GLP-1, GIP, Amylin

Disqualifiers: Gastrointestinal disorders, Hormone therapy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this clinical study is to find out if NNC0662-0419 is safe and effective to be taken together with other medicines, like birth control pills, and emptying of the stomach in women not able to become pregnant living with overweight or obesity. There are 3 study treatments in this study, participants will get all of the treatments, NNC0662-0419 the treatment being tested, Altavera a type of birth control pill, Acetaminophen a common type of mild painkiller.

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

Inclusion Criteria

Considered generally healthy, except for overweight or obesity, based on medical history, physical examination, and results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator

I am a woman who cannot become pregnant.

I am between 18 and 64 years old.

Exclusion Criteria

Known or suspected hypersensitivity to study intervention(s) or related products

I have used or plan to use hormone replacement therapy within the past 28 days.

I have a serious digestive disorder that affects how my body absorbs medicine or nutrients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NNC0662-0419, Altavera, and Acetaminophen. NNC0662-0419 is administered subcutaneously once weekly, Altavera is administered as tablets, and Acetaminophen is given with a standardized meal.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NNC0662-0419

How Is the Trial Designed?

Group I: NNC0662-0419 with oral contraceptive (Altavera) and acetaminophen Experimental Treatment 3 Interventions

Participants will receive once-weekly subcutaneous NNC0662-0419, with multiple doses administered over the treatment period. An oral contraceptive will be administered as a number of tablets per treatment period, with dosing conducted under supervised conditions. In addition, a single dose of acetaminophen will be administered as part of a standardized meal during treatment period.

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