NNC0662-0419 for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Novo Nordisk A/S

Disqualifiers: Hypersensitivity, ECG abnormalities, High HbA1c, others

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

Compensation: Varies

Number of Visits: 30

Duration: 1 day

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, NNC0662-0419, for individuals with overweight or obesity. The main goal is to measure the medicine's concentration in participants' blood after one dose and to assess its safety and tolerability. Participants will receive a single injection under the skin and might experience some side effects. The trial suits individuals aged 18 to 55 with a BMI between 24.0 and 34.9. Participants should be of Japanese, Chinese, or non-Asian descent, based on their parents' backgrounds. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that NNC0662-0419 has been tested in individuals with overweight or obesity to assess its safety and tolerability. In these studies, participants received various doses of the treatment via injection. Results from these tests indicated that the medication was generally well-tolerated, with only mild to moderate side effects reported.

This trial is a Phase 1 study, marking one of the first instances of testing the treatment in humans. The primary goal is to ensure the treatment's safety. So far, the doses used in earlier tests have proven safe enough to warrant further study. However, as with any new treatment, some risks or side effects may still be unidentified. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about NNC0662-0419 for obesity because it offers a new way to tackle weight loss with a potentially novel mechanism of action. Most current treatments focus on appetite suppression or altering fat absorption, but NNC0662-0419 might work differently by targeting specific metabolic pathways. This subcutaneous treatment could offer more precise control over dosage and absorption, potentially leading to more effective and consistent results. Additionally, with multiple dosage options being explored, there’s potential for personalized treatment plans to suit individual patient needs.

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

Research has shown that NNC0662-0419 is being tested in this trial to determine its potential in aiding weight loss for individuals with obesity. Participants will receive different doses of NNC0662-0419 to assess its effectiveness. Early studies suggest that varying doses of this medication might assist those who are overweight or obese in losing weight. Losing even 5% of body weight can improve health, a common goal in obesity treatments. Although detailed information from human studies is still being collected, the mechanism of this medicine offers hope for effective weight management. ^{1 2 3 5 6}

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 study is for Japanese, Chinese, and non-Asian individuals who are living with overweight or obesity. Participants will receive a single dose of the new medicine NNC0662-0419 to assess its levels in the blood and how well it's tolerated.

Inclusion Criteria

For Chinese participants: both parents of Chinese descent

Body mass index (BMI) between 24.0 and 34.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

I am between 18 and 55 years old.

Exclusion Criteria

Glycated haemoglobin (HbA1c) greater than or equal to >= 6.5 percent (%) (48 millimoles per liter [mmol/mol]) at screening

Calcitonin >= 50 nanogram per liter (ng/L) at screening

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of NNC0662-0419 subcutaneously

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

End of study visit on Day 29

What Are the Treatments Tested in This Trial?

Interventions

• NNC0662-0419

Trial Overview The trial is examining NNC0662-0419, a new medication not yet available by prescription. It involves a one-time subcutaneous injection to evaluate safety, tolerability, and pharmacokinetics in people with overweight or obesity.

How Is the Trial Designed?

Group I: NNC0662-0419 (Dose 3) Experimental Treatment 1 Intervention

Participants will receive a SD of NNC0662-0419 subcutaneously.

Group II: NNC0662-0419 (Dose 2) Experimental Treatment 1 Intervention

Participants will receive a SD of NNC0662-0419 subcutaneously.

Group III: NNC0662-0419 (Dose 1) Experimental Treatment 1 Intervention

Participants will receive a single dose (SD) of NNC0662-0419 subcutaneously.

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/NCT07184632

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 ...

2. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9662-8110.html

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 ...

3. withpower.com withpower.com/trial/phase-1-obesity-11-2024-4faa3

NNC0662-0419 for Obesity · Info for Participants Research shows that losing even 5% of body weight can lead to significant health improvements for people with obesity. This level of weight loss is often used ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06737536

A First-in-human Research Study on How NNC0662-0419 ... These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior ...

5. novonordisk-trials.com novonordisk-trials.com/trials-conditions/all-trials-v2/NN9662-8159.html

A Research Study on How a Dose of NNC0662-0419 ... 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 ...

6. synapse.patsnap.com synapse.patsnap.com/drug/1aafc4c268bf4462bb9d8e3cafc53fda

NNC-06620419 - Drug Targets, Indications, Patents A single- and multiple-ascending dose study to investigate safety, tolerability and pharmacokinetics of NNC0662-0419 in participants living with overweight or ...