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Active Not Recruiting NCT07352969

A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients

Conditions: Hypertension

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 352
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Location: Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension

Eligibility Criteria

Inclusion Criteria: 1. Signed informed consent. 2. Males or females aged 18 to 75 years. 3. Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication 4. Mean sitting SBP ≥140 mmHg and \< 170 mmHg measured by OBPM. 5. Participants able to understand and comply with study procedures. Exclusion Criteria: 1. Known history of secondary hypertension. 2. Orthostatic hypotension. 3. Laboratory parameter assessments outside of range at screening: * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \> 2× Upper Limit of Normal (ULN) * Total Bilirubin \> 1.5× ULN * International Normalized Ratio (INR) \> 2.0 * Serum Potassium \> 5 mg/L * Estimated Glomerular Filtration Rate (eGFR) ≤ 45 mL/min/1.73m² * QTcF \> 480 ms 4. Medical condition, other than hypertension, requiring treatment with RAAS inhibitor. 5. Current or history of intolerance to ACEi and/or ARBs. 6. Acute myocardial infarction (AMI), unstable angina, percutaneous coronary intervention (PCI) , coronary artery bypass graft (CABG), ischemic or hemorrhagic stroke, transient ischemic attack, or clinically significant cardiac arrhythmias within 6 months prior to screening. Any history of congestive heart failure. Other protocol-defined inclusion/exclusion criteria may apply

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07352969). StuddyBuddy aggregates publicly available trial information.