NCT07352969Active, not recruitingPhase 2
A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients
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
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 352 (actual)
- First submitted
- 13 Jan 2026
- Start date
- 5 Feb 2026
- Primary completion date
- 27 Mar 2029
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- High blood pressure
- NCT number
- NCT07352969
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 352
- From 5 Feb 2026 to the primary completion date, 27 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- 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
Other illness
- Known history of secondary hypertension.
- Current or history of intolerance to ACEi and/or ARBs.
Lab values
- 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
Other
- Orthostatic hypotension.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.