270 Participants NeededMy employer runs this trial

NNC0662-0419 for Type 2 Diabetes

Recruiting at 65 trial locations
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 a new treatment called NNC0662-0419 for people with type 2 diabetes. The researchers aim to assess the safety and effectiveness of this experimental medicine compared to a placebo and semaglutide, a medication already approved for diabetes. Participants will receive one of these treatments at random. Individuals with type 2 diabetes, HbA1c levels between 7% and 10%, and a willingness to lose more than 25% of their current weight may be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking any diabetes or obesity medications other than those specified in the trial at least 90 days before screening, except for short-term insulin treatment for up to 14 days or insulin for gestational diabetes.

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

Earlier studies tested NNC0662-0419 in people and showed promising results. Research indicates that the doses of this new treatment were safe and generally well-tolerated, with participants reporting no major side effects. However, this treatment is still under investigation.

For semaglutide, another treatment in the trial, its safety is well-documented. The FDA has approved it for treating type 2 diabetes, indicating a well-understood safety profile.

Overall, these findings suggest that both treatments are generally safe for participants, but further study is needed to fully understand the safety of NNC0662-0419.12345

Why do researchers think this study treatment might be promising for type 2 diabetes?

NNC0662-0419 is unique because it introduces a novel approach to treating Type 2 Diabetes by using a dose-escalating method administered subcutaneously, which may enhance the body's response over time. Unlike current standard treatments like Metformin or insulin injections, which primarily focus on managing blood sugar levels, NNC0662-0419 might target different pathways to improve insulin sensitivity. Researchers are excited about this treatment because it offers the potential for more personalized and effective diabetes management, possibly improving outcomes for patients who do not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that NNC0662-0419, which participants in this trial may receive, may help treat type 2 diabetes. In an earlier study, 44% of people taking NNC0662-0419 reached certain health goals, compared to 33% of those taking a placebo. This suggests that the treatment might effectively manage blood sugar levels.

Semaglutide, another treatment option in this trial, is already an approved medication for type 2 diabetes. Studies have found it significantly lowers blood sugar levels and body weight. In one study, nearly half of the participants using semaglutide achieved healthier blood sugar levels. The current trial compares both treatments to evaluate their effectiveness.12367

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 18-75 with type 2 diabetes whose average blood sugar (HbA1c) is between 7.0% and 10%. Participants should be willing to lose a significant amount of weight. People with certain eye problems or who have recently used other diabetes or weight loss drugs can't join.

Inclusion Criteria

Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) as assessed by central laboratory at screening
I am willing to lose more than 25% of my current weight.
I am between 18 and 75 years old.
See 1 more

Exclusion Criteria

Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire
I have not taken diabetes or obesity medication in the past 90 days, except short-term insulin.
I do not have uncontrolled or unstable diabetic eye disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NNC0662-0419, semaglutide, or placebo subcutaneously once weekly in a dose-escalating manner

40 weeks
Weekly visits (in-person)

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 compares different doses of a new drug, NNC0662-0419, against placebo and semaglutide (an approved diabetes medicine). Participants are randomly assigned to one of these groups to see which treatment best lowers blood sugar.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: NNC0662-0419Experimental 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

NCT07415954 | A Research Study Comparing How Well ...

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo ...

A Research Study on How Well Different Doses of the ...

The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study ...

A Research Study on How Well Different Doses of the ...

The purpose of the study is to find out if NNC0662-0419 is safe and effective for treating people living with overweight or obesity. There are 2 study ...

NNC0662-0419 for Type 2 Diabetes

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo ...

NNC0662-0419 Clinical Trials

Results showed that 44% of patients taking NNC0662-0419 met this criteria, compared to 33% of patients on placebo. This difference was ...

A First-in-human Research Study on How NNC0662-0419 ...

Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

A Research Study Comparing How Well Different Doses of ...

This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo ...