A Research Study Comparing Different Ways of Increasing the Dose of NNC0519-0130 in Participants With Overweight or Obesity

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: NNC0519-0130

Study type: Interventional

Funder types: Industry

Identifiers

NCT06718998

U1111-1298-9340 (Other Identifier)

NN9541-7760

2023-508940-23 (Other Identifier)

Details and patient eligibility

About

Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female of non-childbearing potential, or male.
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 27.0 and 44.9 kilogram per square meter (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered to be otherwise healthy 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 disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to (>=) 6.5 percentage (48 millimoles per mole [mmol/mol]) at screening.
• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication 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: Parallel Assignment

Masking: None (Open label)

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114 participants in 4 patient groups

Arm 1: NNC0519-0130

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase.

Treatment:

Drug: NNC0519-0130

Arm 2: NNC0519-0130

Experimental group

Description:

Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase.

Treatment:

Drug: NNC0519-0130

Arm 3: NNC0519-0130

Experimental group

Description:

Participants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase.

Treatment:

Drug: NNC0519-0130

Arm 4: NNC0519-0130

Experimental group

Description:

Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase.

Treatment:

Drug: NNC0519-0130