NNC0662-0419 for Obesity

Not currently recruiting at 24 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Novo Nordisk A/S
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, NNC0662-0419 (an experimental treatment) and Semaglutide, to determine their safety and effectiveness for individuals with obesity. Participants will receive one of these treatments or a placebo (a harmless substance resembling the treatment) to compare outcomes. It suits adults with a body mass index (BMI) of 30 or above who are committed to losing at least 25% of their body weight. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important obesity research.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications prescribed for obesity or weight management at least 90 days before screening.

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

Earlier studies tested NNC0662-0419 for safety and tolerance in individuals who are overweight or have obesity. Most participants handled the treatment well, and researchers found the doses to be safe. This suggests potential safety for humans, but further research is necessary for confirmation.

Semaglutide, another treatment in this trial, is already approved for weight loss and manages obesity. It may cause side effects such as nausea and diarrhea, but these are typically mild and manageable. Semaglutide has a strong safety record for weight loss, making it a reliable choice for many.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about NNC0662-0419 for obesity because it introduces a novel approach to weight management. Unlike most current treatments that often involve lifestyle changes or medications like orlistat and liraglutide, NNC0662-0419 is a new experimental drug administered subcutaneously and designed for dose escalation. This unique delivery method could potentially enhance its effectiveness and tolerability. Additionally, it offers an alternative mechanism of action that may provide benefits beyond what existing therapies offer, sparking interest in its potential to better address obesity.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that Semaglutide, one of the treatments in this trial, is highly effective for weight loss. In several studies, participants using Semaglutide lost significant weight, with some losing more than 14% of their body weight. Specifically, one study found that 76% of participants lost at least 5% of their weight. Meanwhile, NNC0662-0419, another treatment option in this trial, remains under investigation. Early research suggests it might aid weight loss in people with obesity, but more data is needed for confirmation. Overall, Semaglutide has a proven track record, while NNC0662-0419 is still under evaluation.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 adults aged 18 or older with obesity (BMI of 30 or higher) who are committed to losing at least 25% of their body weight. Both men and women can join, regardless of gender identity.

Inclusion Criteria

I am committed to losing at least 25% of my body weight.
I am 18 years old or older.
My sex assigned at birth is male or female.
See 1 more

Exclusion Criteria

I have not used any weight loss medications in the past 90 days.
I have been diagnosed with diabetes.
Known or suspected hypersensitivity to study intervention(s) or related products
See 1 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 or semaglutide, or their respective placebos, administered subcutaneously in a dose-escalation manner

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NNC0662-0419
  • Semaglutide

Trial Overview

The study compares different ways of increasing the dose of a new drug called NNC0662-0419 against placebo, as well as comparing it to semaglutide and its placebo. The goal is to see if NNC0662-0419 is safe and helps with weight loss.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention
Group II: NNC0662-0419Experimental Treatment1 Intervention
Group III: NNC0662-0419 placeboPlacebo Group1 Intervention
Group IV: Semaglutide placeboPlacebo Group1 Intervention

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

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... Efficacy of Once-weekly NNC0662-0419 in Participants Living With Overweight or Obesity. 100 Clinical Results associated with NNC-06620419.

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

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

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

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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 ...