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

Innovent Biologics

Status and phase: Not yet enrolling; Phase 2

Conditions: Hypertension

Treatments: Drug: IBI3016; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07352969

CIBI3016A201

Details and patient eligibility

About

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

Full 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.

Enrollment: 352 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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352 participants in 6 patient groups, including a placebo group

IBI3016 dose 4

Experimental group

Description:

subcutaneous injection

Treatment:

Drug: IBI3016

IBI3016 dose 1

Experimental group

Description:

subcutaneous injection

Treatment:

Drug: IBI3016

IBI3016 dose 2

Experimental group

Description:

subcutaneous injection

Treatment:

Drug: IBI3016

placebo

Placebo Comparator group

Description:

subcutaneous injection

Treatment:

Other: Placebo

IBI3016 dose 3

Experimental group

Description:

subcutaneous injection

Treatment:

Drug: IBI3016

IBI3016 dose 5

Experimental group

Description:

subcutaneous injection

Treatment:

Drug: IBI3016