A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

Официальное название

A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity

Обзор

The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.

Вмешательства

• Препарат Cagrilintide
  Cagrilintide is administered subcutaneously .
• Препарат Placebo Cagrilintide
  Placebo Cagrilintide is administered subcutaneously.

Первичные конечные точки

• Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box [Срок оценки: From baseline (Day 2) to end of treatment (Day 127)]

Вторичные конечные точки (9)

• Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box [Срок оценки: From baseline (Day 2) to end of treatment (Day 127)]
• Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box [Срок оценки: From baseline (Day 2) to end of treatment (Day 127)]
• Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box [Срок оценки: From baseline (Day 2) to end of treatment (Day 127)]
• Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS) [Срок оценки: From baseline (Day 1) to end of treatment (Day 126)]
• Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption [Срок оценки: From baseline (Day 1) to end of treatment (Day 126)]
• Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness [Срок оценки: From baseline (Day 1) to end of treatment (Day 126)]
• Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS [Срок оценки: From baseline (Day 1) to end of treatment (Day 126)]
• • Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score [Срок оценки: From baseline (Day -1) to end of treatment (Day 125)]
• Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score [Срок оценки: From baseline (Day -1) to end of treatment (Day 125)]

Критерии участия

Критерии включения

• Male or female (sex at birth).
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
• Considered to be generally healthy, except for overweight or obesity, 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.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
• Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening.
• History of type 1 or type 2 diabetes mellitus
• Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening.
• Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues.
• Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening.
• Previous dosing of marketed or non-marketed amylin-based compounds.

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: NCT07557953 · NN9833-8421 · U1111-1325-8810 · 2025-524206-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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