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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: IBI3016; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jinling Fan; Phone Number: 0512-69566088; Email: jinling.fan@innoventbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Beijing Anzhen Hospital, Capital Medical University
      • Principal Investigator: Jun Cai
      • Contact: Jun Cai; Phone Number: 010-81992130; Email: caijun7879@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI3016 dose 4; subcutaneous injection	Drug: IBI3016; Solution of Injection
Experimental: IBI3016 dose 1; subcutaneous injection	Drug: IBI3016; Solution of Injection
Experimental: IBI3016 dose 2; subcutaneous injection	Drug: IBI3016; Solution of Injection
Placebo Comparator: placebo; subcutaneous injection	Other: Placebo; 0.9% sodium chloride saline solution
Experimental: IBI3016 dose 3; subcutaneous injection	Drug: IBI3016; Solution of Injection
Experimental: IBI3016 dose 5; subcutaneous injection	Drug: IBI3016; Solution of Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SBP by OBPM	Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM)	From baseline through month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean 24hr SBP by ABPM	Change from baseline at Month 3 in mean 24hr SBP by ambulatory blood pressure measurement (ABPM)	From baseline through month 3
Change in SBP and DBP by OBPM	Change from baseline through month 6 in SBP and diastolic blood pressure (DBP) by OBPM	From baseline through month 6
Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM	From baseline through month 6	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	Percentage Change from baseline through month 24 in Angiotensinogen (AGT) by blood test	From baseline through month 24

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 6, 2026
• Primary Completion (Estimated): March 27, 2029
• Study Completion (Estimated): March 27, 2029

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: CIBI3016A201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No