Status:
COMPLETED
A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Overweight
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study is open to Chinese adults aged 18 to 60 with overweight or obesity. People can join the study if they have a Body Mass Index from 24 to 40.0 kg/m2. Survodutide is a medicine being develope...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06492135
Start Date
August 12 2024
End Date
April 15 2025
Last Update
April 23 2025
Active Locations (1)
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1
Shanghai Central Hospital of Xuhui District
Shanghai, China, 200031