A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBI3016, Placebo.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter, 24 Months Treatment Duration, Dose Finding Study, to Evaluate Efficacy, Safety and Pharmacodynamics of IBI3016 in Mild to Moderate Hypertensive Patients
Overview
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
Detailed description
Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of IBI3016 in patients with mild to moderate hypertension. Multiple doses of IBI3016 will be tested against placebo, administered as subcutaneous injection.
Interventions
- Drug IBI3016
Solution of Injection - Other Placebo
0.9% sodium chloride saline solution
Primary outcome measures
- Change in SBP by OBPM [Time frame: From baseline through month 3]
Secondary outcome measures (4)
- Change in Mean 24hr SBP by ABPM [Time frame: From baseline through month 3]
- Change in SBP and DBP by OBPM [Time frame: From baseline through month 6]
- Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM [Time frame: Change from baseline through month 6 in Mean 24hr, mean daytime, mean nighttime SBP and DBP by OBPM]
- Percentage Change in AGT by blood test [Time frame: From baseline through month 24]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anzhen Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07352969 · CIBI3016A201