Clinical trial
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
Recruiting now · Phase 1 · 1 countries · Registry ID NCT07557953
Recruiting nowPhase 1Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 64 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity
Full registry 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.
Treatments and study arms
Cagrilintide
Drug
Cagrilintide is administered subcutaneously .
Placebo Cagrilintide
Drug
Placebo Cagrilintide is administered subcutaneously.
Primary outcomes
Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack boxFrom baseline (Day 2) to end of treatment (Day 127)
Measured in percentage (%).
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Parexel International GmbH🇩🇪 Berlin, Germany