A Research Study to Compare How Much of the Medicine NNC0519-0130 is in the Blood of People With Overweight or Obesity Who Receive 2 Preparations of the Medicine

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: NNC0519-0130 C; Drug: NNC0519-0130 B

Study type: Interventional

Funder types: Industry

Identifiers

NCT06642571

NN9541-4919

U1111-1307-3788 (Other Identifier)

Details and patient eligibility

About

This study will look into a new study medicine called NNC0519-0130 to improve the treatment option for people living with excess body weight or type 2 diabetes or both. The purpose of this study is to compare the amount of NNC0519-0130 in the blood of participants who have excess body weight. The study comprises two parts and the participants will receive both preparations NNC0519-0130 B and NNC0519-0130 C, which treatment the participants get is decided by chance. The study will last for about 24 weeks.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of non-childbearing potential.
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body Mass Index (BMI) between 27.0 kilogram per square meter (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• 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.

Exclusion criteria

• Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole [mmol/mol]) at screening.
• Use of prescription medicinal products or nonprescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen, acetylsalicylic acid, or topical medication (including eye drops for pupil dilation) not reaching systemic circulation, within 14 days before screening.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 4 patient groups

Part 1a: NNC0519-0130 C and NNC0519-0130 B

Experimental group

Description:

Participants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.

Treatment:

Drug: NNC0519-0130 B

Drug: NNC0519-0130 C

Part 1b: NNC0519-0130 B and NNC0519-0130 C

Experimental group

Description:

Participants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.

Treatment:

Drug: NNC0519-0130 B

Drug: NNC0519-0130 C

Part 2a: NNC0519-0130 B and NNC0519-0130 C

Experimental group

Description:

Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C.

Treatment:

Drug: NNC0519-0130 B

Drug: NNC0519-0130 C

Part 2b: NNC0519-0130 C and NNC0519-0130 B

Experimental group

Description:

Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B.

Treatment:

Drug: NNC0519-0130 B

Drug: NNC0519-0130 C