A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: NNC0113-5840

Study type: Interventional

Funder types: Industry

Identifiers

NCT07566390

U1111-1328-9401 (Other Identifier)

NN9695-8150

Details and patient eligibility

About

The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female
2. Age 18-55 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 25.0 and 34.9 kilogram per meter square (kg/m2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
4. 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 and visit 2, day -1, as judged by the investigator.

Exclusion criteria

1. Known or suspected hypersensitivity to study intervention(s) or related products.
2. Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. Glycosylated haemoglobin (HbA1c) more than or equal to (≥) 6.5 percent (%) [48 millimole per mole (mmol/mol)] at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 7 patient groups, including a placebo group

Cohort 1 NNC0113-5840

Experimental group

Description:

Participants will be randomized to receive NNC0113-5840 single dose level 1 subcutaneously.

Treatment:

Drug: NNC0113-5840

Cohort 2 NNC0113-5840

Experimental group

Description:

Participants will be randomized to receive NNC0113-5840 single dose level 2 subcutaneously.

Treatment:

Drug: NNC0113-5840

Cohort 3 NNC0113-5840

Experimental group

Description:

Participants will be randomized to receive NNC0113-5840 single dose level 3 subcutaneously.

Treatment:

Drug: NNC0113-5840

Cohort 4 NNC0113-5840

Experimental group

Description:

Participants will be randomized to receive NNC0113-5840 single dose level 4 subcutaneously.

Treatment:

Drug: NNC0113-5840

Cohort 5 NNC0113-5840

Experimental group

Description:

Participants will be randomized to receive NNC0113-5840 single dose level 5 subcutaneously.

Treatment:

Drug: NNC0113-5840

Cohort 6 NNC0113-5840

Experimental group

Description:

Participants will be randomized to receive NNC0113-5840 single dose level 6 subcutaneously.

Treatment:

Drug: NNC0113-5840

Placebo matching NNC0113-5840

Placebo Comparator group

Description:

Participants will receive placebo matched to NNC0113-5840 subcutaneously.

Treatment:

Drug: Placebo