48 Participants NeededMy employer runs this trial

NNC0113-5840 for Obesity

Recruiting at 1 trial location
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if NNC0113-5840, an experimental treatment, is safe for individuals with excess body weight. Participants will receive either the new treatment or a placebo (an inactive treatment) to compare effects. The trial tests six different dose levels of NNC0113-5840 to identify the most effective and safe dose. Suitable candidates have a body mass index (BMI) between 25 and 34.9, indicating overweight due to extra body fat. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for this trial?

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

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

Research shows that the safety of NNC0113-5840 remains under investigation, as it is in the early testing stages. Detailed safety information is not yet available. This Phase 1 trial marks the first time the drug is tested in people. The main goal is to determine its safety and how well participants tolerate different doses. Participants will receive one of these doses, and researchers will closely monitor for any side effects. With no previous human studies, this trial will provide the first safety information. This stage is crucial for understanding how the drug works in the body and identifying any potential risks.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about NNC0113-5840 for obesity because it offers a fresh approach to weight management. Unlike current treatments that often focus on appetite suppression or metabolic rate enhancement, NNC0113-5840 is administered subcutaneously, potentially allowing for more direct and consistent absorption. This treatment is being tested in multiple dosage levels, which could help tailor the therapy to individual needs, offering a personalized treatment experience. With obesity being a complex condition, having a new treatment that works differently from the standard options could be a game-changer in effectively managing weight.

What evidence suggests that NNC0113-5840 might be an effective treatment for obesity?

Studies have shown that 44% of patients taking NNC0113-5840 experienced positive results, compared to 33% of those taking a placebo. The trial will test different dose levels of NNC0113-5840, with participants randomized into various treatment arms, including a placebo group. These findings suggest that the treatment might benefit people with obesity more than no treatment. NNC0113-5840 affects specific parts of the body involved in weight control. Although research remains in the early stages, these initial findings offer promise for those seeking new weight loss options.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 18-55 who are overweight or have mild obesity (BMI between 25.0 and 34.9) due to excess body fat, and are otherwise healthy based on medical exams and lab tests.

Inclusion Criteria

I am male or female.
I am between 18 and 55 years old.
3. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of NNC0113-5840 or placebo subcutaneously

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • NNC0113-5840

Trial Overview

The study is testing a new medicine called NNC0113-5840 against a placebo (inactive treatment). Participants are randomly assigned to receive either the new drug or placebo to see if the medicine is safe and effective for weight management.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 6 NNC0113-5840Experimental Treatment1 Intervention
Group II: Cohort 5 NNC0113-5840Experimental Treatment1 Intervention
Group III: Cohort 4 NNC0113-5840Experimental Treatment1 Intervention
Group IV: Cohort 3 NNC0113-5840Experimental Treatment1 Intervention
Group V: Cohort 2 NNC0113-5840Experimental Treatment1 Intervention
Group VI: Cohort 1 NNC0113-5840Experimental Treatment1 Intervention
Group VII: Placebo matching NNC0113-5840Placebo 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

A Research Study Investigating How a New Medicine ...

Not yet recruiting. A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity.

A Research Study Investigating How a New Medicine ...

The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight.

NNC0113-5840 Clinical Trials

In this study, 44% of patients on NNC0113-5840 met the criteria for an overall responder, compared to 33% of patients on placebo. Key secondary ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40961952/

Once-weekly semaglutide 7·2 mg in adults with obesity ...

Background: Once-weekly subcutaneous semaglutide 2·4 mg is approved for weight management in people with obesity and related complications; however, some ...

NNC0113-5840 for Obesity · Info for Participants

The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39089293/

Efficacy and safety of once-weekly semaglutide 2·4 mg ...

Semaglutide 2·4 mg provided superior reduction in bodyweight and reversion to normoglycaemia versus placebo in participants with obesity and prediabetes.