132 Participants NeededMy employer runs this trial

NNC6989-0001 for Obesity

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 the new medicine, NNC6989-0001, is safe and tolerable for individuals with overweight or obesity. Participants will receive either the actual medicine or a placebo, selected randomly. Ideal candidates are healthy individuals with a body mass index (BMI) between 25 and 39.9 who have not recently participated in weight loss programs or used weight loss medications. 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 medicine.

Will I have to stop taking my current medications?

Yes, you will need to stop taking most prescription and non-prescription medications 14 days before the screening. However, routine multivitamins and occasional use of over-the-counter pain relievers like acetaminophen are allowed.

Is there any evidence suggesting that NNC6989-0001 is likely to be safe for humans?

Research on the new medicine NNC6989-0001 remains in the early stages. It is being tested for safety and tolerability in individuals who are overweight or have obesity. Detailed information from past studies on how well people handle this treatment is not yet available.

As a Phase 1 trial, this marks the first time the treatment is tested in humans. This phase emphasizes safety, with researchers closely monitoring for any side effects. Although specific data on NNC6989-0001 is not yet available, Phase 1 trials help identify risks early. Participants in these trials receive careful monitoring to detect any potential problems.12345

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

Most treatments for obesity, like lifestyle changes, medications such as orlistat, and procedures like bariatric surgery, focus on reducing calorie intake or altering hormonal signals to control appetite. However, NNC6989-0001 is unique because it introduces a new active ingredient specifically designed to target metabolic pathways involved in energy regulation. This innovative approach not only promises more effective weight management but also potentially reduces side effects associated with current treatments. Researchers are excited about NNC6989-0001's potential to provide a more targeted and efficient solution for individuals struggling with obesity.

What evidence suggests that NNC6989-0001 might be an effective treatment for obesity?

Research is testing NNC6989-0001 to determine its effectiveness in helping people with obesity lose weight. Participants in this trial will receive either the investigational drug NNC6989-0001 or a placebo that matches the active drug in appearance. Although detailed results from human studies are not yet available, researchers are studying this drug for its potential impact on the body's weight control mechanisms. Novo Nordisk, the company conducting this research, has previously developed successful weight-loss drugs, and some of their experimental drugs have led to significant weight loss in patients. While NNC6989-0001 remains in the early testing stages, there is hope it could aid in weight management. More results are needed to confirm its effectiveness.12345

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 healthy adults aged 18-55 who are overweight or have obesity (BMI between 25 and up to 39.9, depending on the study part). Participants must not be able to become pregnant and need to pass basic health checks.

Inclusion Criteria

I am not able to have children.
* Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m\^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m\^2 for Part B (MAD part).
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, 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 Part A

Participants receive either NNC6989-0001 or placebo for Part A of the study

7 days
Daily visits for monitoring

Treatment Part B

Participants receive either NNC6989-0001 or placebo for Part B of the study

14 days
Daily 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

  • NNC6989-0001

Trial Overview

The study is testing a new medicine called NNC6989-0001 compared with a placebo. Participants will be randomly assigned to receive either the new drug or an inactive treatment, to see if the medicine is safe and well-tolerated.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NNC6989-0001Experimental Treatment1 Intervention
Group II: 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

Novo Nordisk Advances New First‑in‑Human Obesity Drug ...

The study tests an experimental drug, NNC6989‑0001 A, against a placebo that looks the same. The goal is to see if the new treatment is safe and ...

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This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is ...

NNC6989-0001 for Obesity

This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity.

A Study to See How Safe a New Medicine (NNC6989-0001 ...

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring ...

NNC6989-0001 A Clinical Trials

The ongoing clinical trial for NNC6989-0001 A is exploring whether the drug can help individuals manage their weight effectively. This single ...