HypertensionPhase 2NCT07352969
A Dose Finding Study of IBI3016 in Mild to Moderate Hypertensive Patients
A Phase 2 study testing IBI3016 in people with Hypertension, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- IBI3016
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2026to 27 Mar 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
Official title: 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
Read the 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.
- Conditions
- Hypertension
- Being tested
- IBI3016, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3016Drug
Solution of Injection
PlaceboOther
0.9% sodium chloride saline solution
| Study group | Role | What they receive |
|---|---|---|
| IBI3016 dose 4 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| IBI3016 dose 1 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| IBI3016 dose 2 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| placebo | Placebo comparator | subcutaneous injection Receives: Other: Placebo |
| IBI3016 dose 3 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
| IBI3016 dose 5 | Experimental | subcutaneous injection Receives: Drug: IBI3016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SBP by OBPM
Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM)
Measured: From baseline through month 3
Secondary outcomes (4)
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 3 in mean 24hr SBP by ambulatory blood pressure measurement (ABPM)
Measured: 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
Measured: From baseline through month 6
Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM
From baseline through month 6
Measured: 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
Measured: From baseline through month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start5 Feb 2026
- Primary completion27 Mar 2029 (estimated)
- Study completion27 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352969
- Sponsor's protocol ID
- CIBI3016A201
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07352969
- Acronym / sponsor ID
- CIBI3016A201
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 27 Mar 2029 (estimated)
- Study completion
- 27 Mar 2029 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IBI3016 dose 4 | Experimental | Drug: IBI3016subcutaneous injection |
| IBI3016 dose 1 | Experimental | Drug: IBI3016subcutaneous injection |
| IBI3016 dose 2 | Experimental | Drug: IBI3016subcutaneous injection |
| placebo | Placebo comparator | Other: Placebosubcutaneous injection |
| IBI3016 dose 3 | Experimental | Drug: IBI3016subcutaneous injection |
| IBI3016 dose 5 | Experimental | Drug: IBI3016subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Known history of secondary hypertension.
- Orthostatic hypotension.
- Laboratory parameter assessments outside of range at screening：
- Medical condition, other than hypertension, requiring treatment with RAAS inhibitor.
- Current or history of intolerance to ACEi and/or ARBs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBI3016Solution of Injection | Drug | IBI3016 dose 1, IBI3016 dose 2, IBI3016 dose 3, IBI3016 dose 4, IBI3016 dose 5 |
| Placebo0.9% sodium chloride saline solution | Other | placebo |
Primary outcome
Change in SBP by OBPM
Time frame: From baseline through month 3
Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM)
4 secondary outcomes
Change in Mean 24hr SBP by ABPM
Time frame: From baseline through month 3
Change in SBP and DBP by OBPM
Time frame: From baseline through month 6
Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM
Time frame: 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
Time frame: From baseline through month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBI3016 in people with Hypertension, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SBP by OBPM (time frame: From baseline through month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.