NNC0662-0419 for Obesity

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

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

Disqualifiers: Diabetes, ECG abnormalities, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the new medicine NNC0662-0419 for individuals with overweight or obesity. Researchers aim to determine the treatment's safety and efficacy by comparing it to a placebo (a non-active treatment). Participants will receive either the experimental treatment or the placebo. This study may suit those with a Body Mass Index (BMI) of 27 or higher who face weight-related issues such as high blood pressure or sleep apnea. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the early-stage development of a potential new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used certain diabetes-related medications within 90 days before the trial.

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

Research has shown that NNC0662-0419 has undergone testing in people. In a previous study with 803 adults, 83.4% completed the trial. Importantly, no major differences in serious side effects appeared compared to a placebo, indicating that NNC0662-0419 is generally well-tolerated. However, as with any treatment, some individuals might experience side effects. For more specific information, discussing concerns with the study team is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat, or surgical options, NNC0662-0419 offers a novel approach by being administered subcutaneously. This method allows for the drug to be absorbed directly into the bloodstream, potentially leading to more immediate effects. Researchers are particularly excited because this treatment involves a unique multi-phase dosage strategy, which includes a multiple ascending dose phase, a dose range finding, and a 2-week escalation. This structured approach could optimize the effectiveness and safety of the treatment, offering a new hope for individuals struggling with obesity.

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

Research has shown that NNC0662-0419, which participants in this trial may receive, might help people with obesity lose weight. This treatment affects parts of the body that control hunger and energy use. Early results from human studies are promising, indicating it could help reduce body weight. Losing even 5% of body weight can greatly improve health for people with obesity, and this treatment aims to achieve such results. Although still under study, initial tests suggest its potential to help manage weight effectively. ^{1 2 3 4 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 trial is for individuals living with overweight or obesity. Specific details about who can join are not provided, but typically participants must meet certain health criteria and not be taking medications that could interfere with the study.

Inclusion Criteria

Considered eligible 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

Body Mass Index (BMI) at screening: For Part A: 27.0-39.9 kg/m^2, For Part B and Part C: ≥27.0 kg/m^2 with the presence of at least one weight-related comorbidity or ≥30.0 kg/m^2

I am either male or female by birth.

Exclusion Criteria

Calcitonin ≥50 ng/L at screening

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

Any condition, unwillingness, or inability that, in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A: Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of NNC0662-0419 or placebo

up to 40 weeks

Treatment Part B: Dose Range Finding (DFR)

Participants receive doses to find the optimal range of NNC0662-0419 or placebo

up to 36 weeks

Treatment Part C: 2-week Escalation

Participants undergo a 2-week dose escalation of NNC0662-0419 or placebo

2 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 is testing different doses of a new medicine called NNC0662-0419 against a placebo to see if it's safe and effective in treating overweight or obesity. Participants will randomly receive either the actual medicine or a placebo without active ingredients.

How Is the Trial Designed?

Group I: NNC0662-0419 Experimental Treatment 1 Intervention

Participants will be randomized to receive NNC0662-0419 subcutaneously (s.c.). The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).

Group II: Placebo Placebo Group 1 Intervention

Participant will be randomized to receive placebo in: The study will be conducted in 3 parts. Part A: Multiple ascending dose (MAD), Part B: Dose range finding (DFR) and Part C (2-week escalation).

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 ...