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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07352969

Enrollment

352

Registered

2026-01-20

Start date

2026-02-06

Completion date

2029-03-27

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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

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

DRUGIBI3016

Solution of Injection

OTHERPlacebo

0.9% sodium chloride saline solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

CONTACTJinling Fan

jinling.fan@innoventbio.com0512-69566088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026