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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

China1 site

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing

Other trials in China

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 groups in NCT04179669
Study groupRoleWhat they receive
IBI306ExperimentalParticipants received IBI306 150 mg subcutaneously Q2W or 450mg Q4W for 12 weeks.
Receives: Drug: IBI306
placeboExperimentalParticipants 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.

  1. Percentage of LDL-C decreased from baseline injection.

    Measured: at 12 weeks

Secondary outcomes (3)

  1. Percentage change of LDL-C from baseline

    Measured: to 24 weeks

  2. Changes in LDL-C levels relative to baselin

    Measured: at 12 and 24 weeks

  3. 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.

  1. First posted27 Nov 2019
  2. Study start20 Dec 2019
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

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)
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

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.

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