NCT04031742

Brief Summary

A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 29, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

July 22, 2019

Last Update Submit

August 8, 2023

Conditions

Homozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

  • Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).

    Baseline and Week 12

  • Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

    Baseline and Week 12

Other Outcomes (2)

  • Number of investigational product-related adverse events.

    Baseline and Week 12

  • Number of ADA and Nab.

    Baseline and Week 12

Study Arms (2)

Part 1: IBI306

EXPERIMENTAL

Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks.

Biological: IBI306

Part 2: IBI306

EXPERIMENTAL

Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks.

Biological: IBI306

Interventions

IBI306BIOLOGICAL

Administered by subcutaneous injection

Part 1: IBI306

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females ≥ 18 to ≤ 80 years of age
  • Diagnosis of homozygous familial hypercholesterolemia
  • LDL cholesterol ≥ 130 mg/dL (3.4mmol/L)
  • Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
  • Bodyweight of ≥ 40 kg at screening

You may not qualify if:

  • History of liver transplant
  • Uncontrolled hypertension
  • Moderate to severe renal dysfunction
  • Active liver disease or hepatic dysfunction
  • Known sensitivity to any of the products to be administered during dosing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Homozygous Familial Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipoproteinemia Type IILipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 \[ Time Frame: Baseline and Week 12 \]
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2019

First Posted

July 24, 2019

Study Start

September 29, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

CN(1)