NCT07352969

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
35mo left

Started Feb 2026

Typical duration for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Feb 2026Mar 2029

First Submitted

Initial submission to the registry

January 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2029

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

January 13, 2026

Last Update Submit

January 13, 2026

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Mean 24hr SBP by ABPM

    From baseline through month 3

  • Change in SBP and DBP by OBPM

    From baseline through month 6

  • 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

  • Percentage Change in AGT by blood test

    From baseline through month 24

Study Arms (6)

IBI3016 dose 4

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

IBI3016 dose 1

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

IBI3016 dose 2

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

placebo

PLACEBO COMPARATOR

subcutaneous injection

Other: Placebo

IBI3016 dose 3

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

IBI3016 dose 5

EXPERIMENTAL

subcutaneous injection

Drug: IBI3016

Interventions

IBI3016DRUG

Solution of Injection

IBI3016 dose 1IBI3016 dose 2IBI3016 dose 3IBI3016 dose 4IBI3016 dose 5
PlaceboOTHER

0.9% sodium chloride saline solution

placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Jinling Fan

CONTACT

0512-69566088jinling.fan@innoventbio.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 20, 2026

Study Start

February 6, 2026

Primary Completion (Estimated)

March 27, 2029

Study Completion (Estimated)

March 27, 2029

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

CN(1)