A Study on How NNC0174-1213 Works in People With Overweight or Obesity.

Novo Nordisk

Status and phase: Enrolling; Phase 1

Conditions: Overweight; Obesity

Treatments: Drug: Placebo A (NNC0174 1213 A); Drug: Cagrilintide B; Drug: NNC0174-1213 A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06719011

NN9839-8082

U1111-1308-5620 (Other Identifier)

Details and patient eligibility

About

This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called "cagrilintide" or a placebo (a "dummy medicine" similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.

Enrollment: 177 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male.
• Age 18-55 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Body weight more than or equal to (>=) 80.0 kilograms (kg) at screening.
• 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

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Exposure to an investigational medicinal product within 2 months or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
• Participants report prior receipt of an amylin and/or calcitonin receptor agonist within the last 6 months.
• Impaired liver function defined as any of the below:
• Aspartate aminotransferase (AST) more than or equal to (>=) 2 times upper limit of normal at screening
• Alanine aminotransferase (ALT) more than or equal to (>=) 2 times upper limit of normal at screening
• Bilirubin more than (>) 1.5 times upper limit of normal at screening (except if known or proven Gilbert's syndrome)
• Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (<) 75 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) at screening.
• Glycated haemoglobin (HbA1c) more than or equal to (>=) 6.5 percent (%) (48 millimoles per mole (mmol/mol) at screening.
• Any clinically significant body weight change more than or equal to (>=) 5 percent (%) self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening .
• Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
• Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
• Vitamin D (25-hydroxycholecalciferol) less than (<) 12 nanogram per milliliter (ng/mL) (30 nanometer (nM) at screening
• Parathyroid hormone (PTH) outside normal range at screening
• Total calcium outside normal range at screening
• Calcitonin more than or equal to (>=) 50 nanogram per liter (ng/L) at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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177 participants in 6 patient groups

Part A: NNC0174-1213 (SD1-SD5)

Experimental group

Description:

Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.

Treatment:

Drug: NNC0174-1213 A

Drug: Cagrilintide B

Drug: Placebo A (NNC0174 1213 A)

Part A: Cagrilintide (SDA and SDB)

Experimental group

Description:

Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2. Cagrilintide SDB will be administered in cohort 3 and 4.

Treatment:

Drug: NNC0174-1213 A

Drug: Cagrilintide B

Drug: Placebo A (NNC0174 1213 A)

Part A: Placebo

Experimental group

Description:

Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.

Treatment:

Drug: NNC0174-1213 A

Drug: Cagrilintide B

Drug: Placebo A (NNC0174 1213 A)

Part B: NNC0174-1213 (MD1-MD5)

Experimental group

Description:

Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.

Treatment:

Drug: NNC0174-1213 A

Drug: Cagrilintide B

Drug: Placebo A (NNC0174 1213 A)

Part B: Cagrilintide (MDA)

Experimental group

Description:

Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.

Treatment:

Drug: NNC0174-1213 A

Drug: Cagrilintide B

Drug: Placebo A (NNC0174 1213 A)

Part B: Placebo

Experimental group

Description:

Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.

Treatment:

Drug: NNC0174-1213 A

Drug: Cagrilintide B

Drug: Placebo A (NNC0174 1213 A)