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

Официальное название

A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.

Обзор

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.

Вмешательства

• Препарат NNC0174-1213 A
  Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
• Препарат Cagrilintide B
  Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
• Препарат Placebo A (NNC0174 1213 A)
  Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.

Первичные конечные точки

• Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213 [Срок оценки: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46)]
• Part B: Number of treatment emergent adverse events (TEAE) [Срок оценки: From first administration (Day 1) to completion of the end of study visit (Day 67)]

Вторичные конечные точки (4)

• Part A: AUC; area under the NNC0174 1213 plasma concentration-time curve [Срок оценки: From pre-dose on Day 1 to completion of the end of study visit (Day 46)]
• Part A: Cmax; maximum observed NNC0174 1213 plasma concentration [Срок оценки: From pre-dose on Day 1 to completion of the end of study visit (Day 46)]
• Part B: AUC; area under the NNC0174 1213 plasma concentration-time curve [Срок оценки: From first administration (Day 1) to completion of the end of study visit (Day 67)]
• Part B: Cmax; maximum observed NNC0174 1213 plasma concentration [Срок оценки: From first administration (Day 1) to completion of the end of study visit (Day 67)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• ICON Early Phase Services, LLC — San Antonio
• ICON Early Phase Services, LLC — Salt Lake City

Идентификаторы

NCT: NCT06719011 · NN9839-8082 · U1111-1308-5620

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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