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Non-Familial Hypercholesterolemia and Mixed HyperlipidemiaPhase 3NCT07473960

IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia

A Phase 3 study testing IBI306 in people with Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed hyperlipidemia. Approximately 198 participants were planned to be enrolled in the study. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IBI306
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
198 participants
Where
1 siteChina
Study dates
1 Apr 2026to 28 Feb 2027
Phase
Phase 3
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

  • 1. Male or female, ≥18 and ≤75 years of age on the day of signing informed consent.
  • 2. Fasting LDL-C ≥ 2.6 mmol/L and < 4.9 mmol/L measured in a local laboratory at screening and randomization.
  • 3. Fasting triglyceride (TG) ≤ 5.64 mmol/L measured in a local laboratory at screening and randomization.
  • 4. According to the 2023 Chinese Guidelines for the Management of Blood Lipids, the 10-year risk of atherosclerotic cardiovascular disease is assessed as low or moderate (< 10%).
  • 5. Understand the study-related procedures and methods, and voluntarily participate in the study and sign the informed consent form.

Who cannot join

  • 1. History of any of the following medical or treatment conditions:
  • Known allergies to the study drugs or their components, or severe allergic reactions to other antibody drugs.
  • Previously diagnosed as ASCVD, including acute coronary syndrome, stable coronary heart disease, post-revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic disease, etc.
  • Confirmed or suspected familial hypercholesterolaemia according to UK Simon Broome criteria.
  • History of acute or chronic heart failure with New York Heart Association (NYHA) class III or IV, or left ventricular ejection fraction < 40% within 3 months prior to screening.
  • Previous diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, or supraventricular tachycardia poorly controlled by medication, etc.
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  • Poorly controlled hypertension, defined as sitting systolic blood pressure (SBP) ≥ 160 mmHg or diastolic blood pressure (DBP) ≥ 100 mmHg at screening or randomization.
  • Previous diagnosis of nephrotic syndrome, severe liver disease, Cushing's syndrome, and other diseases that significantly affect blood lipid levels.
  • History of type 1 diabetes mellitus, or type 2 diabetes mellitus with one of the following: (1) glycosylated hemoglobin (HbA1c) ≥ 8.5% at screening; (2) severe hypoglycemia within 6 months prior to screening; (3) insulin injection ≥ 2 times per day prior to screening.
  • History of malignancy within 5 years prior to screening.
  • Treatment with a PCSK9 monoclonal antibody within 6 months prior to screening or treatment with inclisiran prior to screening.
  • Participation in a clinical study of any medical device or other drug within 3 months prior to screening (except for screening failure), or less than 5 half-lives from the most recent dose of the investigational drug at screening.
  • Treatment with systemic cyclosporine within 3 months prior to screening.
  • Long-term continuous (≥ 7 days) or multiple (≥ 3 times) systemic glucocorticoid therapy within 3 months prior to screening (except for topical, intraocular, intranasal, inhaled, or intra-articular injection).
  • Treatment with weight-loss drugs or bariatric surgery within 3 months prior to screening.
  • History of drug or alcohol abuse prior to screening. Average weekly alcohol intake: more than 21 units for males and more than 14 units for females (1 unit = 360 mL of beer, or 150 mL of red wine, or 45 mL of distilled spirits/white wine).
  • 2. Paricipants whose laboratory test parameters meet any of the following criteria at screening or randomization:
  • Estimated glomerular filtration rate ( eGFR) < 30 mL/min/1.73 m 2 using the MDRD formula.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN), or total bilirubin > 1.5 × ULN.
  • Creatine kinase (CK) > 3 × ULN.
  • Hypothyroidism or hyperthyroidism, defined as thyroid-stimulating hormone (TSH) below the lower limit of normal or exceeding 1.5 times the ULN, respectively.
  • Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) and HBV DNA copy number ≥ 1.0 × 10 3 /mL, or positive for hepatitis C antibody ( except for those who have received complete anti-hepatitis C treatment and whose HCV RNA is below the lower limit of detection ).
  • Positive for human immunodeficiency virus (HIV) antibodies or syphilis-specific antibodies.
  • 3. Female participants of childbearing potential who did not use contraception within 4 weeks prior to screening, or male or female participants who did not agree to use contraception as specified in this protocol throughout the study and for 15 weeks after the last treatment.
  • 4. Female participants who are pregnant or lactating.
  • 5. The investigator believes that the subject has poor compliance, or there are factors that may bring unacceptable safety risks or affect the study results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 Monotherapy in Participants With Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia (CREDIT-5)

This is a multi-center, randomized, double-blind, placebo-controlled phase III clinical study evaluating the efficacy and safety of IBI306 monotherapy in Chinese Paricipants with non-familial hypercholesterolemia and mixed hyperlipidemia. Approximately 198 participants were planned to be enrolled in the study. The entire study period includes a screening period of no more than 2 weeks, a run-in period of 4 weeks, a double-blind treatment period of 12 weeks, and a safety follow-up period after the last treatment. Participants were required to maintain a stable and healthy lifestyle throughout the trial.

Being tested
IBI306, placebo
Medical subject headings
Hyperlipoproteinemia Type II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBI306Drug

    IBI306 150 mg Q2W

  • placeboDrug

    Placebo Q2W

  • placeboDrug

    Placebo Q4W

  • IBI306Drug

    IBI306 450 mg Q4W

Study groups in NCT07473960
Study groupRoleWhat they receive
IBI306 150 mg Q2WExperimentalNot described
Receives: Drug: IBI306
Placebo Q2WPlacebo comparatorNot described
Receives: Drug: placebo
IBI306 450 mg Q4WExperimentalNot described
Receives: Drug: IBI306
Placebo Q4WPlacebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in LDL-C

    Measured: week 12

Secondary outcomes (9)

  1. Proportion of participants with LDL-C of less than 2.6 mmol/L

    Measured: week 12

  2. Proportion of participants with LDL-C of less than 1.8 mmol/L

    Measured: week 12

  3. Proportion of participants with LDL-C reduction of ≥50% from baseline

    Measured: week 12

  4. Change from baseline in LDL-C

    Measured: week 12

  5. Change and percentage change from baseline in non-HDL-C

    Measured: week 12

  6. Change and percentage change from baseline in ApoB

    Measured: week 12

  7. Change and percentage change from baseline in vLDL-C

    Measured: week 12

  8. Change and percentage change from baseline in Lp(a)

    Measured: week 12

  9. Change and percentage change from baseline in PCSK9

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2026
  2. Study start1 Apr 2026
  3. Primary completion6 Sep 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

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
Single blind
Who is masked
Participant
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07473960
Sponsor's protocol ID
CIBI306B302
Status last verified
Aug 2026
First submitted
11 Mar 2026
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IBI306 in people with Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia, 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 26 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 14 Aug 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 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?

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?

Percent change from baseline in LDL-C (time frame: week 12). 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 NCT07473960.

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 14 Aug 2026.

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