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Nonalcoholic Fatty Liver DiseasePhase 1NCT06044467

The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects

A Phase 1 study testing Anti-human CCL24 monoclonal antibody (CM-101) - Part One and Anti-human CCL24 monoclonal antibody (CM-101) - Part Two in people with Nonalcoholic Fatty Liver Disease, run by ChemomAb Ltd. at 1 site in Israel.

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

A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) < 3 that are in general good health and have normal liver functions to be treated with CM-101. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonalcoholic Fatty Liver Disease
What is being tested?
Anti-human CCL24 monoclonal antibody (CM-101) - Part One and Anti-human CCL24 monoclonal antibody (CM-101) - Part Two
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteIsrael
Study dates
11 Dec 2018to 27 Apr 2020
Phase
Phase 1
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

  • Patients with US confirmation of NAFLD without evidence of NASH;
  • Patients with normal liver function tests (i.e. ALT, AST and ALP).
  • Patients in general good health expected for the preceding 6 months;
  • Women of childbearing potential must agree to use an approved form of contraception prior to study entry and for the duration of study participation through 60 days after the last dose of the study medication. Confirmation that female patients are not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women;
  • Male patients must agree to use a barrier method of contraception or abstinence for the duration of study participation through 60 days after the last dose of the study medication;
  • Patient must be able to read, understand, and sign the informed consent forms (ICF), communicate with the investigator, and understand and comply with protocol requirements

Who cannot join

  • Patients with medical/surgical history of gastric bypass surgery, orthotopic liver transplant (OLT) or patients that are planned for such interventions;
  • Documented history of chronic liver disease (e.g., autoimmune hepatitis (>1:160 ANA with histologic features), Wilson's disease, Hemochromatosis (Ferritin >500 ug/L and percent iron saturation >45%), Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Alcoholic Liver Disease);
  • Presence of chronic viral hepatitis:
  • Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg) positive);
  • Chronic hepatitis C virus (HCV) infection (HCV Ab and HCV ribonucleic acid (HCV RNA) positive).
  • Patients cured of HCV infection less than 5 years prior to the Screening visit are not eligible;
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  • History of or current diagnosis of HCC;
  • Known human immunodeficiency virus (HIV) infection (HIV Ab and HIV ribonucleic acid (HIV RNA) positive);
  • Patients with diabetes mellitus type 1;
  • Patients with uncontrolled diabetes mellitus type 2, i.e. HbA1c ≥ 9% (75 mmol/mol) at the time of screening or patients that are treated with insulin;
  • Patients treated with chronic medication including but not limited to anti-retrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins, or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within the 12 weeks of screening;
  • Patients treated with the below listed medications can be enrolled into the study if these medications are deemed medically necessary, cannot be stopped and the investigator anticipates their dose will remain stable during the study:
  • Stable doses of anti-diabetic medications (e.g. metformin, sulfonylureas, SGLT2 inhibitors, glitazones (thiazolidinediones), dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 analogs) for at least 6 months prior to screening.
  • Stable doses of ACE inhibitors, angiotensin II receptor antagonists, beta-blockers and thiazide diuretics for at least 6 months prior to screening.
  • Stable doses of fibrates, statins, niacin, ezetimibe for at least 6 months prior to screening.
  • Stable doses of vitamin E for at least 6 months prior to screening.
  • Replacement therapy (e.g., thyroxine, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed as long as the treatment is stable forat least 6 months prior to screening. For further clarification Insulin treatment is not allowed.
  • Patients with the following medical conditions:
  • Cardiovascular conditions:
  • Unstable angina (clinical definition)
  • History of myocardial infarction, cardiac catheterization (for any reason) or coronary artery bypass graft within 18 months of screening
  • Atrial fibrillation
  • Congestive Heart failure (clinical definition) or hypertrophic cardiomyopathy
  • Heart valve disorder (i.e., prosthetic valve or known hemodynamically relevant valve disease)
  • Unstable angina
  • Uncontrolled thyroid disease
  • Portal hypertension
  • CNS disturbance such as history of Stroke (CVA and/or TIA), Parkinson's disease, Alzheimer's disease, or history of seizure disorders.
  • Autoimmune disease that has required systemic treatment in the 2 years preceding study screening (i.e., with the use of disease-modifying agents, corticosteroids or immunosuppressive drugs).
  • Clinically significant renal dysfunction defined as a serum creatinine concentration >1.4 mg/dL (females) or >1.6 mg/dL (males) and/or a blood urea nitrogen (BUN) concentration >45 mg/dL at screening.
  • Patients diagnosed or treated for any malignancy within 5 years of screening, except in situ malignancy, or low-risk prostate, skin (basal or squamous cell cancer or other localized non-melanoma) or cervix cancer after curative therapy.
  • Any laboratory abnormality or condition that, in the investigator's opinion, could adversely affect the safety of the patient or impair the assessment of study results.
  • Presence of any condition that could, in the opinion of the investigator, compromise the patient's ability to participate in the study, including a history of substance abuse or a psychiatric condition requiring hospitalization or emergency room visit within 2 years of Screening;
  • Patients with the following blood test abnormalities:
  • Abnormal coagulation tests: INR,
  • Total bilirubin (TB) ≥2 ULN,
  • Serum Albumin < 3.4 g/dL,
  • Platelet count <130 × 10^9/L;
  • History of or current significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average);
  • Patients with history of substance abuse (including alcohol abuse as defined above) in the past or a positive screen for drugs of abuse (opioids and cannabinoids) or alcohol at screening;
  • Female patients who are pregnant or nursing, or male/female patients who are planning a pregnancy during the course of the study;
  • Patients that are unavailable for follow-up assessments or any concern the investigator may have for patient's compliance with the protocol procedures;
  • Patients that are currently participating or have participated in an interventional clinical study within 3 months prior to screening

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 91120

Other trials in Israel

About this study

Official title: A Phase 1B, Repeated Dose Study, to Evaluate the Safety, PD and PK Profile of CM-101 in NAFLD Patients With Normal Liver Function Tests and Stable NAFLD/NASH Patients With NAFLD Activity Score (NAS) < 3-The SPARK Study

A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) < 3 that are in general good health and have normal liver functions to be treated with CM-101.

Read the detailed description

This study is designed to assess the safety and preliminary pharmacodynamics of repeated administrations of CM-101 in two subject populations. The objective of part one of this study is to demonstrate that repeated treatment with CM-101 will be safe and well tolerated in NAFLD subjects that have normal liver functions and are in general good health. A second expansion part will be carried out that will include patients with NAFLD/NASH Activity Score (NAS) < 3 that are in general good health and have normal liver functions.

Being tested
Anti-human CCL24 monoclonal antibody (CM-101) - Part One, Anti-human CCL24 monoclonal antibody (CM-101) - Part Two, Placebo - Study Part One, Placebo - Study Part Two
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

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

  • Anti-human CCL24 monoclonal antibody (CM-101) - Part OneDrug

    Anti-human CCL24 monoclonal antibody (CM-101) - Part One

  • Anti-human CCL24 monoclonal antibody (CM-101) - Part TwoDrug

    Anti-human CCL24 monoclonal antibody (CM-101) - Part Two

  • Placebo - Study Part OneDrug

    Placebo Comparator

  • Placebo - Study Part TwoDrug

    Placebo Comparator

Study groups in NCT06044467
Study groupRoleWhat they receive
Anti-human CCL24 monoclonal antibody (CM-101) - study Part OneExperimentalAnti-human CCL24 monoclonal antibody (CM-101) NAFLD subjects that have normal liver functions - (Cohort 1: 2.5 mg/kg intravenously and Cohort 2: 5.0 mg/kg subcutaneously)
Receives: Drug: Anti-human CCL24 monoclonal antibody (CM-101) - Part One
Placebo - Study Part OnePlacebo comparatorPlacebo Comparator
Receives: Drug: Placebo - Study Part One
Anti-human CCL24 monoclonal antibody (CM-101) - Study Part TwoExperimentalAnti-human CCL24 monoclonal antibody (CM-101) NAFLD/NASH patients with NAS < 3 that are in general good health and have normal liver functions - 2.5 mg/kg intravenous infusion
Receives: Drug: Anti-human CCL24 monoclonal antibody (CM-101) - Part Two
Placebo - Study Part TwoPlacebo comparatorPlacebo Comparator
Receives: Drug: Placebo - Study Part Two

What is being measured

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

  1. Incidence and characteristics of adverse events (AEs) occurring following multiple doses

    Incidence and characteristics of adverse events (AEs) occurring following multiple doses

    Measured: Up to 18 weeks

  2. Evaluation of the development of anti-drug antibodies (ADA) - Study Part 1

    Evaluation of the development of anti-drug antibodies (ADA) following repeated administrations of CM-101 -

    Measured: Up to 18 weeks

Secondary outcomes (20)

  1. Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Maximum CM-101 plasma concentration (Cmax) - Study Part 1

    Plasma PK parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)

    Measured: Up to 18 weeks

  2. Plasma Pharmacokinetics (PK) parameters of CM-101 - Time to Cmax (tmax) - Study Part 1

    Plasma PK parameters of CM-101 following multiple administrations - Time to Cmax (tmax)

    Measured: Up to 18 weeks

  3. Plasma Pharmacokinetics (PK) parameters of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf - Study Part 1

    Plasma PK parameters of CM-101 following multiple administrations - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf

    Measured: Up to 18 weeks

  4. Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Terminal elimination rate constant (λz) - Study Part 1

    Plasma PK parameters of CM-101 - Terminal elimination rate constant (λz)

    Measured: Up to 18 weeks

  5. Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Terminal elimination half-life (T½) - Study Part 1

    Plasma PK parameters of CM-101 - Terminal elimination half-life (T½)

    Measured: Up to 18 weeks

  6. Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Maximum CM-101 plasma concentration (Cmax) - Study Part 2

    Plasma PK parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)

    Measured: Up to 18 weeks

  7. Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Time to Cmax (tmax) - Study Part 2

    Plasma PK parameters of CM-101 - Time to Cmax (tmax)

    Measured: Up to 18 weeks

  8. Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf - Study Part 2

    Plasma PK parameters of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf

    Measured: Up to 18 weeks

  9. Plasma Pharmacokinetics (PK) parameters of CM-101 - Terminal elimination rate constant (λz) - Study Part 2

    Plasma PK parameters of CM-101 following multiple administrations - Terminal elimination rate constant (λz)

    Measured: Up to 18 weeks

  10. Plasma Pharmacokinetics (PK) parameters of CM-101 - Terminal elimination half-life (T½) - Study Part 2

    Plasma PK parameters of CM-101 following multiple administrations - Terminal elimination half-life (T½)

    Measured: Up to 18 weeks

  11. Evaluation of the development of anti-drug antibodies (ADA) following repeated administrations of CM-101 - Study Part 2

    Evaluation of the development of anti-drug antibodies (ADA) of CM-101

    Measured: Up to 18 weeks

  12. Liver function test: ALT (alanine aminotransferase) - Study Part 2 Only

    Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - ALT (alanine aminotransferase)

    Measured: Over a treatment period of 18 weeks

  13. Liver function test: AST (Aspartate Aminotransferase) - Study Part 2 Only

    Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - Liver function test: AST (Aspartate Aminotransferase)

    Measured: Over a treatment period of 18 weeks

  14. Liver function test: GGT (gamma-glutamyltransferase) - Study Part 2 Only

    Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - Liver function test: GGT (gamma-glutamyltransferase)

    Measured: Over a treatment period of 18 weeks

  15. Liver function test: ALP (Alkaline Phosphatase) - Study Part 2 Only

    Percentage and absolute change from baseline in liver enzymes (liver function test) in multiple timepoints - Liver function test:ALP (Alkaline Phosphatase)

    Measured: Over a treatment period of 18 weeks

  16. Change from baseline to end of treatment in: fibrosis-4 (FIB-4) score - Study Part 2 Only

    Change from baseline to end of treatment in: fibrosis-4 (FIB-4) score

    Measured: Up to 15 Weeks

  17. Change from baseline to end of treatment in: Aspartate transaminase (AST) ratio - Study Part 2 Only

    Change from baseline to end of treatment in: AST ratio

    Measured: Up to 15 Weeks

  18. Change from baseline to end of treatment in: Alanine aminotransferase (ALT) ratio - Study Part 2 Only

    Change from baseline to end of treatment in: ALT ratio

    Measured: Up to 15 Weeks

  19. Change from baseline to end of treatment in: APRI (AST to platelet ratio index) - Study Part 2 Only

    Change from baseline to end of treatment in: APRI (AST to platelet ratio index)

    Measured: Up to 15 Weeks

  20. Change from baseline to end of treatment in: Nonalcoholic fatty liver disease (NAFLD) Fibrosis Score - Study Part 2 Only

    Change from baseline to end of treatment in: NAFLD Fibrosis Score

    Measured: Up to 15 Weeks

Timeline

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

  1. First posted21 Sep 2023
  2. Study start11 Dec 2018
  3. Primary completion27 Apr 2020
  4. Study completion27 Apr 2020

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06044467
Sponsor's protocol ID
CM-101-I-002
Status last verified
Sep 2023
First submitted
30 Aug 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mor A, Friedman S, Hashmueli S, Peled A, Pinzani M, Frankel M, Safadi R. Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies. Drug Saf. 2024 Sep;47(9):869-881. doi: 10.1007/s40264-024-01436-2. Epub 2024 Jun 1.

    PubMed 38822943

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-human CCL24 monoclonal antibody (CM-101) - Part One and Anti-human CCL24 monoclonal antibody (CM-101) - Part Two in people with Nonalcoholic Fatty Liver Disease, run by ChemomAb Ltd. at 1 site in Israel.

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 43 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 21 Sep 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 Israel. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Incidence and characteristics of adverse events (AEs) occurring following multiple doses (time frame: Up to 18 weeks). The study lists 2 primary outcomes in all. 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 NCT06044467, 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 21 Sep 2023.

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