HypercholesterolemiaPhase 3NCT04289285
Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia
A Phase 3 study testing IBI306 450mg SC Q4W and IBI306 600mg SC Q6W in people with Hypercholesterolemia, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- IBI306 450mg SC Q4W and IBI306 600mg SC Q6W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 804 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2020to 9 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Males and females ≥ 18 to ≤ 75 years of age
- Diagnosis of hypercholesterolemia
- LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
- Very high or high cardiovascular risk
- TG≤500 mg/dL(5.64 mmol/L)
Who cannot join
- Diagnosis of HoFH or HeFH
- Uncontrolled hypertension
- Uncontrolled hyperthyroidism or hypothyroidism
- Severe renal dysfunction
- Known sensitivity to any of the products to be administered during dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of IBI306 in Chinese Non-familial Hypercholesterolemia Subjects at Very High or High Cardiovascular Risk: a Randomized, Double-blind and Placebo-controlled Phase III Study
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects
Read the detailed description
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks
- Conditions
- Hypercholesterolemia
- Being tested
- IBI306 450mg SC Q4W, Placebo SC Q4W, IBI306 600mg SC Q6W, Placebo SC Q6W
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI306 450mg SC Q4WDrug
Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
Placebo SC Q4WDrug
Subjects will receive placebo every 4 weeks subcutaneously.
IBI306 600mg SC Q6WDrug
Subjects will receive IBI306 600mg every 6 weeks subcutaneously.
Placebo SC Q6WOther
Subjects will receive placebo every 6 weeks subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| IBI306 450mg SC Q4W | Experimental | Not described Receives: Drug: IBI306 450mg SC Q4W |
| Placebo SC Q4W | Placebo comparator | Not described Receives: Drug: Placebo SC Q4W |
| IBI306 600mg SC Q6W | Experimental | Not described Receives: Drug: IBI306 600mg SC Q6W |
| Placebo SC Q6W | Placebo comparator | Not described Receives: Other: Placebo SC Q6W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48
Measured: Week 48
Secondary outcomes (3)
The percent of subjects with LDL-C reduction no less than 50% from baseline
Measured: Week 48
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Measured: Week 48
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start29 Apr 2020
- Primary completion9 Feb 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 804 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
- NCT04289285
- Sponsor's protocol ID
- CIBI306B301
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2020
- Last updated
- 11 Apr 2022
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of IBI306 in Chinese Non-familial Hypercholesterolemia Subjects at Very High or High Cardiovascular Risk: a Randomized, Double-blind and Placebo-controlled Phase III Study
- ClinicalTrials.gov ID
- NCT04289285
- Acronym / sponsor ID
- CIBI306B301
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 28 Feb 2020 (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.
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects
Detailed description
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IBI306 450mg SC Q4W | Experimental | Drug: IBI306 450mg SC Q4W |
| Placebo SC Q4W | Placebo comparator | Drug: Placebo SC Q4W |
| IBI306 600mg SC Q6W | Experimental | Drug: IBI306 600mg SC Q6W |
| Placebo SC Q6W | Placebo comparator | Other: Placebo SC Q6W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ≥ 18 to ≤ 75 years of age
- Diagnosis of hypercholesterolemia
- LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
- Very high or high cardiovascular risk
- TG≤500 mg/dL(5.64 mmol/L)
Key exclusion criteria (5 listed)
- Diagnosis of HoFH or HeFH
- Uncontrolled hypertension
- Uncontrolled hyperthyroidism or hypothyroidism
- Severe renal dysfunction
- Known sensitivity to any of the products to be administered during dosing
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 |
|---|---|---|
| IBI306 450mg SC Q4WSubjects will receive IBI306 450mg every 4 weeks subcutaneously. | Drug | IBI306 450mg SC Q4W |
| Placebo SC Q4WSubjects will receive placebo every 4 weeks subcutaneously. | Drug | Placebo SC Q4W |
| IBI306 600mg SC Q6WSubjects will receive IBI306 600mg every 6 weeks subcutaneously. | Drug | IBI306 600mg SC Q6W |
| Placebo SC Q6WSubjects will receive placebo every 6 weeks subcutaneously. | Other | Placebo SC Q6W |
Primary outcome
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48
Time frame: Week 48
3 secondary outcomes
The percent of subjects with LDL-C reduction no less than 50% from baseline
Time frame: Week 48
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Time frame: Week 48
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Time frame: Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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 3 study testing IBI306 450mg SC Q4W and IBI306 600mg SC Q6W in people with Hypercholesterolemia, 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 5 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: finished, as of the sponsor's last update on 11 Apr 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48 (time frame: Week 48). 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 11 Apr 2022.