Recruiting NCT07557953
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cagrilintide, Placebo Cagrilintide.
- Who it may be relevant to
- Registry conditions: Overweight, Obesity. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity
Overview
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.
Interventions
- Drug Cagrilintide
Cagrilintide is administered subcutaneously . - Drug Placebo Cagrilintide
Placebo Cagrilintide is administered subcutaneously.
Primary outcome measures
- Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box [Time frame: From baseline (Day 2) to end of treatment (Day 127)]
Secondary outcome measures (9)
- Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box [Time frame: 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 [Time frame: 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 [Time frame: From baseline (Day 2) to end of treatment (Day 127)]
- Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS) [Time frame: From baseline (Day 1) to end of treatment (Day 126)]
- Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption [Time frame: From baseline (Day 1) to end of treatment (Day 126)]
- Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From baseline (Day -1) to end of treatment (Day 125)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Parexel International GmbH — Berlin
Identifiers
NCT: NCT07557953 · NN9833-8421 · U1111-1325-8810 · 2025-524206-15