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New treatment option for MASH
Official title A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
ClinicalTrials.gov ID: NCT06562361
What this study is testing
What is [68Ga]Ga-DOTA-Cys-ATH001?
[68Ga]Ga-DOTA-Cys-ATH001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mash.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC).The study will also assess the safety of a microdose of 68Ga]Ga-DOTA-Cys-ATH001 and how it is distributed in different parts of the body. The main questions the study aims to answer are: What does the uptake of the [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer look like in the liver of healthy subjects, and in that of patients with MASH and PSC?
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Willing and able to give written informed consent for participation in the trial and able to comply with all trial procedures and requirements.
- Male or female participant aged 18 to 75 years, inclusive, at the screening visit.
- Body mass index (BMI) ≥ 19 and \< 40.0 kg/m2 at the time of the screening visit.
- Women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual...
- combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
You likely can't join if
- Any contraindication for MRI according to a standard checklist used in clinical practice, including claustrophobia, metallic implants or internal...
- Having worked as a metal worker or welder.
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because...
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the screening visit.
- Any malignancy within the past 12 months before the screening visit, with the exception of successfully treated basal cell carcinoma of the skin or...
- Any planned major surgery within the duration of the trial participation.
See the full eligibility criteria
Who can join
- Willing and able to give written informed consent for participation in the trial and able to comply with all trial procedures and requirements.
- Male or female participant aged 18 to 75 years, inclusive, at the screening visit.
- Body mass index (BMI) ≥ 19 and \< 40.0 kg/m2 at the time of the screening visit.
- Women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective...
- combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),
- intra-uterine device [IUD]or intra-uterine hormone-releasing system [IUS]) WOCBP must refrain from donating eggs until 3 months after the last tracer administration. WOCBP with an exclusive male partner who has...
- Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator. Cohort...
- Steatosis according to biopsy, radiology, or controlled attenuation parameter (CAP) (≥ 280 dB/M 8), assessments ≤ 24 weeks prior to the screening visit.
- At least 1 cardiometabolic criteria from the following list: A. BMI ≥ 25 kg/m2 [23 Asia] OR waist circumference (WC) \> 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol/L [100 mg/dL] OR...
- ProC3 ≥ 12.6 ng/mL. Cohort 3 (verified MASH patients) MASH diagnosis based on historical liver biopsy. Participants should have a high level of disease activity with regards to ProC3 as a marker of ongoing fibrogenesis...
- Evidence of steatosis according to biopsy, radiology, or CAP (≥ 280 dB/M) or MRI-PDFF, assessments ≤ 24 weeks prior to the screening visit.
- At least 1 cardiometabolic criteria from the following list: A. BMI ≥ 25 kg/m2 [23 Asia] OR WC \> 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol/L [100 mg/dL] OR 2-hour post-load glucose...
- Historical liver biopsy 24 weeks to 4 weeks prior to inclusion with histologically proven metabolic dysfunction-associated steatotic liver disease (MASLD).
- ProC3 ≥ 12.6 ng/mL. Cohort 4 (fibrostenotic CD patients)
- Fibrostenotic CD as evidenced by persistent luminal narrowing with or without obstructive symptoms as assessed with MRI, ≤ 24 weeks prior to the screening visit OR fibrostenotic CD by positive colonoscopy up to 24 weeks...
- Crohn's disease activity index (CDAI) \< 150
- Calprotectin \< 250
- C-reactive protein (CRP) \< 20 Cohort 5 (PSC patients)
- Large duct PSC, including intrahepatic bile duct involvement, according to MRI/MRCP.
- ProC3 ≥ 12.6 ng/mL
What rules you out
- Any contraindication for MRI according to a standard checklist used in clinical practice, including claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric...
- Having worked as a metal worker or welder.
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the...
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the screening visit.
- Any malignancy within the past 12 months before the screening visit, with the exception of successfully treated basal cell carcinoma of the skin or in situ prostate cancer under active surveillance, with no...
- Any planned major surgery within the duration of the trial participation.
- Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
- Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B or C antibodies and/or human immunodeficiency virus (HIV).
- Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc.).
- Poor peripheral venous access, as judged by the Investigator.
- After 10 minutes of supine rest at the screening visit, any vital signs values outside the following ranges:
- Systolic blood pressure: \ 165 mmHg, or
- Diastolic blood pressure \ 100 mmHg, or
- Pulse \ 90 bpm
- The participant has a change in body weight ≥5%, 3 months before the screening visit.
- The participant has any laboratory abnormality or condition that, in the Investigator's opinion, could adversely affect the safety of the participant or impair the assessment of trial results.
- Clinically significantly abnormal 12-lead ECG recording result or cardiac symptoms as judged by the Investigator.
- The participant is using any prohibited concomitant medications as described in the protocol, at the discretion of the Investigator.
- Current use of any hormone therapy at doses that may cause metabolic interference as judged by the Investigator. Stable hormonal replacement therapy is allowed.
- Currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit or previous participation in another PET imaging trial within the last 12 months.
- Positive screening result for alcohol at the screening visit (cohorts 1a and 1b only).
- Ongoing or previous alcohol abuse, or long-standing excessive intake of alcohol, as judged by the Investigator.
- Presence or history of drug abuse, as judged by the Investigator.
- History of, or current use of anabolic steroids, as judged by the Investigator.
- Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
- The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements. Additional exclusion criteria for all participants (cohorts 2-5):
- The participant is receiving treatment with vitamin E, thiazolidinediones, or glucagon-like peptide-1 receptor agonists unless on a stable dose for 3 months before the screening Visit and is anticipated to maintain the...
- Participants with HbA1c ≥48 mmol/mol (6.5%) at screening without a previous diagnosis of T2D must not take part in the study. Participants with a previous diagnosis of T2D are permitted to enter the study if on a stable...
- Clinically significant disease, apart from T2D, which in the opinion of the Investigator might interfere with the interpretation of the trial results and/or the safety of the participant, or in any other way unsuitable...
- The participant has a severe immune-mediated inflammatory disease (IMID) (e.g., rheumatoid arthritis, spondylarthritis disease spectrum, connective tissue disorders, cutaneous inflammatory conditions such as psoriasis...
- Liver stiffness \> 25 kPa by transient elastography or any sign of decompensation. For cohorts 2 and 3, based on the FibroScan® evaluation on the screening visit, and for cohort 5 based on routine elastography performed...
- For participants with biopsy-confirmed fibrosis stage F2 or F3, the participant has any of the following during the screening period:
- Aspartate aminotransferase (AST) levels \> 5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) levels \> 5 x ULN.
- Alkaline phosphatase (ALP) ≥ 2 x ULN (cohorts 2 and 3) and ALP ≥ 10 (cohort 5).
- Serum creatinine ≥1.5 x ULN or has an estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2 (the revised Lund-Malmö GFR estimating equation will be used).
- International normalized ratio (INR) \>1.3.
- Total TBL ≥ULN (except for patients with a documented history of Gilbert's syndrome if direct bilirubin is within the normal reference range).
- Direct bilirubin ≥ 3 x ULN.
- Platelet count \< 60 x 109/L.
- Presence or history of ascites, hepatic encephalopathy, or variceal bleeding.
- Presence or history of Child-Pugh \> 6 (Class B or C), unless due to therapeutic anticoagulation.
- Presence or history of Model for End-Stage Liver disease (MELD) score \>12 (only for cohorts 2-3). Note: It is the Investigator's decision, in consultation with the Sponsor, to allow participants to enter the study who...
- The participant has a change in body weight ≥ 5% after qualifying liver biopsy. Additional criteria for fibrostenotic CD participants (cohort 4)
- MRI findings consistent with only inflammation, i.e., edema, hyperemic intestinal wall, restricted diffusion, mesenteric lymphadenopathy etc.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
- Uppsala, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden; Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.