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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

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

Key facts

Study ID

NCT07352969

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

352

Starts

2026-02-06

Expected to finish

2029-03-27

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• Males or females aged 18 to 75 years.
• Diagnosis of primary hypertension without anti-HTN medication or with one anti-HTN medication
• Mean sitting SBP ≥140 mmHg and < 170 mmHg measured by OBPM.
• Participants able to understand and comply with study procedures.

You may not qualify if…

• Known history of secondary hypertension.
• Orthostatic hypotension.
• 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
• Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
• Current or history of intolerance to ACEi and/or ARBs.
• 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

Where it is running

• Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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