142 Participants NeededMy employer runs this trial

NNC0721-8060 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 tests a new treatment called NNC0721-8060 to determine its safety and effectiveness for individuals with overweight or obesity. Participants will receive injections of either NNC0721-8060, semaglutide (a medication used for weight management), or a placebo (a substance with no active drug). The trial aims to understand how these treatments assist in weight management. Candidates with a Body Mass Index (BMI) between 27.0 and 34.9, typically indicating overweight due to extra body fat, may be suitable for participation. 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.

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

Research shows that NNC0721-8060 is undergoing its first human trials. Researchers are still gathering detailed safety information. In this early phase, the main goal is to assess the treatment's safety and how well participants tolerate it. As this is the initial human trial, the safety information remains limited and mainly exploratory. Participants in these trials help researchers identify any possible side effects or risks. This stage is crucial to ensure the treatment is safe enough for further testing.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about NNC0721-8060 for obesity because it offers a potentially new way to tackle weight loss. Unlike many current treatments that focus on suppressing appetite or increasing metabolism, NNC0721-8060 is a novel compound designed to be delivered by subcutaneous injection, which could enhance its effectiveness or convenience. This innovative approach might provide an alternative for those who haven't responded well to existing options, such as orlistat or liraglutide. Additionally, the study compares NNC0721-8060 with semaglutide, a well-known treatment, to understand its unique benefits more clearly.

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

Research has shown that NNC0721-8060 is a new treatment under study for its potential to help people with obesity. In this trial, participants will receive NNC0721-8060 as one of the treatment options. It targets parts of the body that control weight, similar to other successful obesity treatments. While specific results are not yet available, the treatment is being tested due to its promising potential for weight loss. NNC0721-8060 is in the early stages of research, and more information will emerge as studies progress.26789

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 people who are overweight or have obesity. Participants should generally be in good health aside from their weight and meet specific age and weight requirements set by the study.

Inclusion Criteria

Body Mass Index (BMI) 27.0-34.9 kg/m² (both inclusive) at screening, with overweight due to excess adipose tissue as judged by the investigator
Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening, as judged by the investigator
My sex at birth is male or female.
See 1 more

Exclusion Criteria

Any disorder, unwillingness or inability which might jeopardise participant safety or compliance with the protocol as judged by the investigator
History of allergies (except seasonal allergies) or history of anaphylactic reactions
I am pregnant, breastfeeding, planning pregnancy, or not using birth control.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive subcutaneous injections of NNC0721-8060, semaglutide, or placebo

5 weeks
Multiple visits for injections and monitoring

Treatment Part B

Continuation of treatment with monitoring for adverse events and pharmacokinetics

8 weeks
Regular visits for monitoring

Treatment Part C

Further treatment and monitoring for changes in body weight and pharmacokinetics

12 weeks
Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NNC0721-8060

Trial Overview

The study is testing a new drug called NNC0721-8060 to see if it is safe and effective for treating overweight or obesity, compared to a placebo (inactive treatment) and semaglutide (an existing medication).

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: NNC0721-8060Experimental Treatment1 Intervention
Group II: SemaglutideActive Control1 Intervention
Group III: 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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Novo Nordisk moved previously undisclosed NNC0721-8060 into a first-in-human obesity trial with semaglutide as an active comparator