A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes

Novo Nordisk

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide; Drug: NNC0662-0419; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07415954

2025-523260-20 (Other Identifier)

U1111-1324-0310 (Other Identifier)

NN9662-8160

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Male or female (sex at birth).
• Age 18-75 years (both inclusive) at the time of signing the informed consent.
• Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole [mmol/mol]) (both inclusive) as assessed by central laboratory at screening.
• Willingness to obtain a high weight loss (greater than [>] 25% of weight at baseline).

Exclusion criteria

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
• Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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270 participants in 3 patient groups, including a placebo group

NNC0662-0419

Experimental group

Description:

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

Treatment:

Drug: NNC0662-0419

Semaglutide

Active Comparator group

Description:

Participants will receive semaglutide s.c. once weekly.

Treatment:

Drug: Semaglutide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo