Heterozygous Familial HypercholesterolemiaPhase 3NCT04179669
Safety and Efficacy of IBI306 in HeFH Patients
A Phase 3 study testing IBI306 in people with Heterozygous Familial 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 80 years
- Conditions the study is for
- Heterozygous Familial 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
- 149 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2019to 30 Jun 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria in order to be included in the study:
- Provide a signed and dated informed consent form
- Men or women 18 to 70 years of age at screening
- Weight ≥ 40 kg during screening
- Confirmed diagnosis of heterozygous familial hypercholesterolemia
- Maintain a low-fat diet and stabilize the current lipid-lowering therapy
Who cannot join
- Subjects who do not meet any of the following exclusion criteria cannot be included in the study:
- Patients diagnosed as homozygous familial hypercholesterolemia
- Dialysis or plasmapheresis performed within 4 months prior to screening
- History of liver transplant
- Subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids within 4 weeks prior to screening
- New York Heart Association (NYHA) grade III or IV heart failure, or recent detection of left ventricular ejection fraction ≤ 30%
- Have serious cardiovascular, cerebrovascular, liver and kidney related diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Safety and Efficacy of IBI306 in Patients With Heterozygous Familial Hypercholesterolemia
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. In the phase I study, IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.
Read the detailed description
The study plans to enroll 148 patients with heterozygous familial hypercholesterolemia. Subjects will maintain a low-fat diet and stable current lipid-lowering therapy for at least 4 weeks and will be randomized into different dose groups at a 1:1 ratio, followed by a 2:1 randomization double-blind treatment with subcutaneous IBI306 150 mg (n=49) or placebo (n=25) every two weeks; or subcutaneous injection of IBI306 450mg (n=49) or placebo (n=25) every four weeks. Treatment lasts for 12 weeks. After 12 weeks, each group enters a 12-week open-label treatment, in which IBI306 subjects continue to receive IBI306, and placebo subjects shift to receive IBI306. The primary endpoint is the percent change in LDL-C levels relative to baseline at 12 weeks. Secondary endpoints include changes in baseline lipid levels, drug safety, and immunogenicity at 12 weeks and 24 weeks. The exploratory endpoint is the population pharmacokinetic profile of IBI306 in Chinese subjects with heterozygous familial hypercholesterolemia. If necessary, the dose of IBI306 will be adjusted accordingly based on the results of the ongoing multi-dose escalation study. After the open period, the subjects will be given a safety visit for 8 weeks.
- Being tested
- IBI306, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI306Drug
Administered by subcutaneous injection
placeboDrug
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| IBI306 | Experimental | Participants received IBI306 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks. Receives: Drug: IBI306 |
| placebo | Experimental | Participants received Placebo 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of LDL-C decreased from baseline injection.
Measured: at 12 weeks
Secondary outcomes (3)
Percentage change of LDL-C from baseline
Measured: to 24 weeks
Changes in LDL-C levels relative to baselin
Measured: at 12 and 24 weeks
The proportion of patients with LDL-C that were 50% lower than baseline
Measured: by 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start20 Dec 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 Heterozygous Familial 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 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
- NCT04179669
- Sponsor's protocol ID
- CIBI306C301
- Status last verified
- Aug 2023
- First submitted
- 25 Nov 2019
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chai M, He Y, Zhao W, Han X, Zhao G, Ma X, Qiao P, Shi D, Liu Y, Han W, An P, Li H, Yan S, Ma Q, Deng H, Qian L, Zhou Y; CREDIT-2 investigators. Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2). BMC Med. 2023 Feb 28;21(1):77. doi: 10.1186/s12916-023-02797-8.
PubMed 36855099
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Safety and Efficacy of IBI306 in Patients With Heterozygous Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04179669
- Acronym / sponsor ID
- CIBI306C301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Nov 2019 (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. In the phase I study, IBI306 was shown to be safe and well tolerated. There was robust reduction in LDL-C, Apo(B), non-HDL-C and lipoprotein (a) in healthy subjects. This study is a randomized, double-blind, placebo-controlled, repeated-dosing, multiple ascending dose trial to evaluate the efficacy and safety of a novel PCSK-9 anti-body, IBI306, in Chinese patients with heterozygous familial hypercholesterolemia.
Detailed description
The study plans to enroll 148 patients with heterozygous familial hypercholesterolemia. Subjects will maintain a low-fat diet and stable current lipid-lowering therapy for at least 4 weeks and will be randomized into different dose groups at a 1:1 ratio, followed by a 2:1 randomization double-blind treatment with subcutaneous IBI306 150 mg (n=49) or placebo (n=25) every two weeks; or subcutaneous injection of IBI306 450mg (n=49) or placebo (n=25) every four weeks. Treatment lasts for 12 weeks. After 12 weeks, each group enters a 12-week open-label treatment, in which IBI306 subjects continue to receive IBI306, and placebo subjects shift to receive IBI306. The primary endpoint is the percent change in LDL-C levels relative to baseline at 12 weeks. Secondary endpoints include changes in baseline lipid levels, drug safety, and immunogenicity at 12 weeks and 24 weeks. The exploratory endpoint is the population pharmacokinetic profile of IBI306 in Chinese subjects with heterozygous familial hypercholesterolemia. If necessary, the dose of IBI306 will be adjusted accordingly based on the results of the ongoing multi-dose escalation study. After the open period, the subjects will be given a safety visit for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI306 | Experimental | Drug: IBI306Participants received IBI306 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks. |
| placebo | Experimental | Drug: placeboParticipants received Placebo 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria in order to be included in the study:
- Provide a signed and dated informed consent form
- Men or women 18 to 70 years of age at screening
- Weight ≥ 40 kg during screening
- Confirmed diagnosis of heterozygous familial hypercholesterolemia
Key exclusion criteria (7 listed)
- Subjects who do not meet any of the following exclusion criteria cannot be included in the study:
- Patients diagnosed as homozygous familial hypercholesterolemia
- Dialysis or plasmapheresis performed within 4 months prior to screening
- History of liver transplant
- Subjects adjusted for treatment of statins, ezetimibe, niacin, omega-fatty acids within 4 weeks prior to screening
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 |
|---|---|---|
| IBI306Administered by subcutaneous injection | Drug | IBI306 |
| placeboAdministered by subcutaneous injection | Drug | placebo |
Primary outcome
Percentage of LDL-C decreased from baseline injection.
Time frame: at 12 weeks
3 secondary outcomes
Percentage change of LDL-C from baseline
Time frame: to 24 weeks
Changes in LDL-C levels relative to baselin
Time frame: at 12 and 24 weeks
The proportion of patients with LDL-C that were 50% lower than baseline
Time frame: by 12 weeks and 24 weeks
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 9 Aug 2023.
- Derived from this study: PubMed 36855099Chai M, He Y, Zhao W, Han X, Zhao G, Ma X, Qiao P, Shi D, Liu Y, Han W, An P, Li H, Yan S, Ma Q, Deng H, Qian L, Zhou Y; CREDIT-2 investigators. Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2). BMC Med. 2023 Feb 28;21(1):77. doi: 10.1186/s12916-023-02797-8.
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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 Heterozygous Familial 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 6 inclusion and 7 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 9 Aug 2023. 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. 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?
Percentage of LDL-C decreased from baseline injection. (time frame: at 12 weeks). 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 NCT04179669, 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 9 Aug 2023.