45 Participants NeededMy employer runs this trial

NNC0662-0419 for Obesity

Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S
Must be taking: Birth control pills
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NNC0662-0419 to determine its safety and effectiveness for women dealing with overweight or obesity. Participants will take this treatment alongside a birth control pill and acetaminophen to assess their combined effects. Women who are generally healthy but live with overweight or obesity might be suitable candidates for this study. 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 it.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that interfere with certain metabolic pathways, like St. John's Wort, at least 14 days before screening. However, routine vitamins and occasional use of common painkillers like acetaminophen are allowed.

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

Previous studies have found NNC0662-0419 to be safe and well-tolerated in individuals who are overweight or have obesity. Participants received doses without major safety concerns, indicating general tolerability. However, as this trial is in its early stages, researchers continue to gather more safety data. Participants will also take Altavera, a birth control pill, and acetaminophen, a common pain reliever. Both are widely used and typically considered safe.12345

Why are researchers excited about this trial's treatments?

Unlike standard obesity treatments that primarily involve lifestyle changes or medications that suppress appetite or alter fat absorption, NNC0662-0419 is unique because it is administered as a once-weekly subcutaneous injection. This delivery method could potentially improve compliance and convenience for patients. Additionally, NNC0662-0419 is combined with an oral contraceptive and acetaminophen, suggesting a novel approach to managing obesity alongside other health considerations. Researchers are excited about this treatment because it offers a new way to address obesity with potentially enhanced effectiveness and fewer lifestyle disruptions.

What evidence suggests that NNC0662-0419 could be an effective treatment for obesity?

Research has shown that NNC0662-0419 is being tested as a new treatment for individuals who are overweight or have obesity. Early results suggest this medicine might increase the number of complete bowel movements. In one study, 48% of participants taking NNC0662-0419 experienced at least one more complete bowel movement per week over several weeks, compared to 35% of those not taking it. This suggests the treatment could aid in weight management. In this trial, participants will receive NNC0662-0419 alongside an oral contraceptive (Altavera) and acetaminophen. However, further studies are needed to confirm its efficacy and safety, especially when used with other medications like birth control pills.12346

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for women aged 18-64 who cannot become pregnant and have overweight or obesity. Participants must be generally healthy aside from their weight, weigh at least 60 kg, and not have certain stomach issues or allergies to the study drugs.

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.
See 1 more

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.
See 4 more

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

Trial Overview

The study tests how safe and effective NNC0662-0419 is when taken with birth control pills (Altavera) and acetaminophen in women with excess body weight. All participants will receive each treatment during the trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: NNC0662-0419 with oral contraceptive (Altavera) and acetaminophenExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

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 profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

NCT07184632 | A Research Study on How Well Different ...

This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find out if ...

A Research Study on How Well Different Doses of the ...

This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity. The purpose of the study is to find ...

NCT07101783 | A Research Study on How a Dose ...

The study is testing the new medicine NNC0662-0419 in people living with overweight or obesity. The purpose of the study is to look into the amount of the new ...

A Research Study Looking Into How NNC0662-0419 ...

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, ...

A Research Study on How Well Different... | Clinical Trial

Overview. Brief Summary. This study tests how well different doses of the medicine NNC0662-0419 help people living with overweight or obesity.

NNC0662-0419 in Overweight or Obesity for Safety and ...

This study is focused on testing a new medicine called NNC0662-0419 in people who have overweight or obesity. The main goal is to understand how much of ...