HypercholesterolemiaPhase 3NCT04709536
A Study of IBI306 in Participants With Hypercholesterolemia
A Phase 3 study testing IBI306 in people with Hypercholesterolemia, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2021to 28 Jan 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
- 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: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)
This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.
- Conditions
- Hypercholesterolemia
- Being tested
- IBI306, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI306Drug
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
PlaceboDrug
Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
| Study group | Role | What they receive |
|---|---|---|
| IBI306 | Experimental | IBI306 administered subcutaneously (SC) Receives: Drug: IBI306 |
| Placebo | Placebo comparator | administered subcutaneously (SC) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
Measured: Baseline to week12
Secondary outcomes (3)
The percent of subjects with LDL-C reduction no less than 50% from baseline
Measured: Baseline to week24
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Measured: Baseline to week24
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Measured: Baseline to week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start9 Feb 2021
- Primary completion9 Nov 2021
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 306 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
- NCT04709536
- Sponsor's protocol ID
- CIBI306B201
- Status last verified
- Oct 2024
- First submitted
- 12 Jan 2021
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qi L, Liu D, Qu Y, Chen B, Meng H, Zhu L, Li L, Wang S, Liu C, Zheng G, Lian Q, Yin G, Lv L, Lu D, Chen X, Xue F, An P, Li H, Deng H, Li L, Qian L, Huo Y. Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. JACC Asia. 2023 Jul 11;3(4):636-645. doi: 10.1016/j.jacasi.2023.04.011. eCollection 2023 Aug.
PubMed 37614541
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)
- ClinicalTrials.gov ID
- NCT04709536
- Acronym / sponsor ID
- CIBI306B201
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 14 Jan 2021 (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.
This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI306 | Experimental | Drug: IBI306IBI306 administered subcutaneously (SC) |
| Placebo | Placebo comparator | Drug: Placeboadministered subcutaneously (SC) |
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 (4 listed)
- 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 |
|---|---|---|
| IBI306Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24 | Drug | IBI306 |
| PlaceboRecombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24 | Drug | Placebo |
Primary outcome
1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12
Time frame: Baseline to week12
3 secondary outcomes
The percent of subjects with LDL-C reduction no less than 50% from baseline
Time frame: Baseline to week24
The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)
Time frame: Baseline to week24
The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline
Time frame: Baseline to week24
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 31 Oct 2024.
- Derived from this study: PubMed 37614541Qi L, Liu D, Qu Y, Chen B, Meng H, Zhu L, Li L, Wang S, Liu C, Zheng G, Lian Q, Yin G, Lv L, Lu D, Chen X, Xue F, An P, Li H, Deng H, Li L, Qian L, Huo Y. Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. JACC Asia. 2023 Jul 11;3(4):636-645. doi: 10.1016/j.jacasi.2023.04.011. eCollection 2023 Aug.
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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 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 4 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 31 Oct 2024. 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?
1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12 (time frame: Baseline to week12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04709536, which also lists 1 linked publication.
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 31 Oct 2024.