Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT06492135
Eligibility Criteria:
Inclusion Criteria:
* Chinese ethnicity
* Age of 18 to 60 years
* 40≥ body mass index (BMI) ≥30 kilogram (kg)/ square meters (m²) at screening, or 30\> BMI ≥27 kg/m² at screening with the presence of at least one of the following weight-related complications
* Hypertension
* Dyslipidemia
* Obstructive sleep apnea
* Cardiovascular disease (CVD) (e.g. heart failure (HF) with New York Heart Association (NYHA) functional class II-III, history of ischemic or hemorrhagic stroke or cerebrovascular revascularization procedure \[e.g. carotid endarterectomy and/or stent\], myocardial infarction (MI), coronary artery disease, or peripheral vascular disease)
* Non-alcoholic steato hepatitis (NASH), as assessed in medical records by histological liver assessment (within the last 6 months) or overweight but otherwise healthy participants with BMI ≥ 24 but \< 27 kg/m² according to the assessment of the investigator, based on a complete medical history, physical examination, vital signs (BP, PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening.
* stable body weight in the 3 months prior to screening visit (defined as no more than 5% change by self-report)
* further inclusion criteria apply
Exclusion Criteria:
* Repeated measurement of sitting blood pressure (BP) ≥160/95 millimeter of mercury (mmHg), or pulse rate (PR) \>100 beats per minute (bpm) after 5 minutes of resting at screening visit.
* Exposure to any glucagon-like-peptide 1 receptor (GLP-1R) agonist (including combination products) within three months prior to screening visit, or any previous exposure to survodutide, or history of relevant allergy or hypersensitivity (including allergy intolerability or lack of efficacy to trial medication or drugs that belongs to the GLP-1R agonist class).
* Trial participants with the following laboratory findings at screening are excluded:
* Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) elevation ≥3× upper limit of normal (ULN)
* Total bilirubin ≥1.2× ULN
* Calcitonin ≥100 picograms per milliliter (pg/mL) (29.26 picomoles per litre (pmol/L))
* Glycosylated hemoglobin A1c (N-(1-deoxy)-fructosyl-hemoglobin) (HbA1c) \> upper limit of normal (ULN)
* History of either chronic or acute pancreatitis or elevation of serum lipase or amylase \>2x ULN as measured by the laboratory at screening
* further exclusion criteria apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06492135
Study Brief:
Protocol Section:
NCT06492135