NNC0662-0419 for Type 2 Diabetes

Recruiting at 61 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novo Nordisk A/S

Must not be taking: Diabetes, Obesity medications

Disqualifiers: Uncontrolled diabetic retinopathy, Hypoglycaemic unawareness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 40 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: NNC0662-0419 Experimental Treatment 1 Intervention

Participants will receive NNC0662-0419 subcutaneously (s.c.) in a dose escalating manner once weekly.

Group II: Semaglutide Active Control 1 Intervention

Participants will receive semaglutide s.c. once weekly.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to their respective investigational medicinal product s.c. once weekly.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen