A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity

Официальное название

Effect of Once-weekly Subcutaneous Administration of NNC0487-0111 on Energy Intake, Appetite and Postprandial Metabolism in Participants With Obesity - a Randomised, Placebo-controlled, Double Blinded Study

Обзор

The purpose of this clinical study is to look at if/how much NNC0487-0111 affects food intake, appetite and metabolism in participants with obesity when compared to placebo. There are 2 study treatments in this study. Participants will inject the study treatment under the skin of your stomach once a week. Participants will get either NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants will get is decided by chance.

Вмешательства

• Препарат NNC0487-0111
  NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.
• Препарат Placebo (matched to NNC0487-0111)
  Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors into a skin fold on the abdomen.

Первичные конечные точки

• Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126 [Срок оценки: From Baseline to Day 126]
• Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182 [Срок оценки: From Baseline to Day 182]
• Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238 [Срок оценки: From Baseline to Day 238]

Вторичные конечные точки (12)

• Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 126 [Срок оценки: From Baseline to Day 126]
• Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 182 [Срок оценки: From Baseline to Day 182]
• Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 238 [Срок оценки: From Baseline to Day 238]
• Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 126 [Срок оценки: From Baseline to Day 126]
• Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 182 [Срок оценки: From Baseline to Day 182]
• Change from baseline in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box to Day 238 [Срок оценки: From Baseline to Day 238]
• Relative change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box to Day 378 [Срок оценки: From Baseline to Day 378]
• Change from baseline in total energy intake across ad libitum breakfast, lunch, evening meal and snack box at Day 378 [Срок оценки: From Baseline to Day 378]
• Change from baseline in total amount of food consumed during ad libitum breakfast, lunch, evening meal and snack box to Day 378 [Срок оценки: From Baseline to Day 378]
• Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 126 [Срок оценки: From Baseline to Day 126]
• Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 182 [Срок оценки: From Baseline to Day 182]
• Change from baseline in energy intake of high fat, sweet food during ad libitum energy intake in the evening snack box to Day 238 [Срок оценки: From Baseline to Day 238]

Критерии участия

Критерии включения

• Male or female (sex at birth).
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• 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.
• Overweight should be due to excess adipose tissue, as judged by the investigator.

Критерии исключения

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• History of type 1 or type 2 diabetes mellitus.
• Glycated hemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) at screening.
• Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issues.
• Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Parexel International GmbH — Berlin

Идентификаторы

NCT: NCT07508020 · NN9490-8151 · U1111-1319-9246 · 2025-521393-34

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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