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larazotide

Phase 3

Celiac Disease | Peptides | Gastrointestinal |9 Meters Biopharma, Inc.|Trials Updated: Sep 20, 2017

larazotide development status

Highest phase Phase 3 (NCT03569007)
Phase scored for NMTRQPhase 2
Registered trials 1 across 1 sponsor since Jun 2018

larazotide target and mechanism

Molecular targetCHRNB4, CHRNA3
Target classPartial Agonist
ModalityPeptides
ChEMBLCHEMBL2105646

Also known as larazotide acetate, AT1001, INN-202

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials5
Total Enrollment419

FDA Designations

No designations recorded

larazotide clinical trials

larazotide · 5 trials · 1 indication

Phase 2 4Phase 1 1
NCT00889473Study of the Efficacy of Larazotide Acetate to Treat Celiac DiseaseCeliac Disease
COMPLETED42 Analytics
NCT00620451Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac DiseaseCeliac Disease
COMPLETED105 Analytics
NCT00492960Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac DiseaseCeliac Disease
COMPLETED171 Analytics
NCT00362856Safety and Tolerability Study of Larazotide Acetate in Celiac Disease SubjectsCeliac Disease
COMPLETED80 Analytics
PHASE2COMPLETED
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
Celiac Disease
NCT0088947342
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PHASE2COMPLETED
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
Celiac Disease
NCT00620451105
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PHASE2COMPLETED
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
Celiac Disease
NCT00492960171
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PHASE2COMPLETED
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
Celiac Disease
NCT0036285680
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Study Endpoints

Primary Endpoints

Response to gluten
6 weeks
Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
duodeno-jejunal biopsies were performed at Baseline and Day 56

Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.

Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Following ingestion of a solution of lactulose and mannitol; lactulose and mannitol excretion was quantified and the LAMA ratio calculated from overnight urine specimens collected on Days 7, 21, 35, 49 and 56.

The primary efficacy endpoint was the Day 49 to Day 7 ratio of urinary LAMA ratios as a response to gluten

To demonstrate the safety and tolerability of multiple, oral doses of larazotide acetate in celiac disease subjects that maintain a gluten-free diet.
Safety measurements were performed at Screening and at Day 0, 7, 14, and 21 ('End of Study'). Any change from baseline value was calculated at each subsequent visit until "End of Study" (Day 21).

Safety endpoints assessed in this study were adverse events, vital signs, hematology, clinical chemistry, urinalysis and ECG

To evaluate the efficacy of multiple dose levels of larazotide acetate in preventing intestinal permeability changes induced by gluten challenge
On Days 0, 6, 13, and 20 subjects drank a solution of lactulose and mannitol. Subject's urine was collected during the day on Day 0 and overnight prior to subsequent visits and analyzed for LAMA recoveries via standardized methodologies.

The primary efficacy outcome was the Day 0-to-Day 14 change in urinary LAMA ratio ( a measure of intestinal permeability) as a response to gluten

Demonstrate the safety and tolerance of single doses of larazotide acetate in patients with controlled celiac disease on a gluten-free diet.
AEs were monitored throughout the study. Clinical laboratory testing was performed at scheduled times throughout the study. ECGs were measured at baseline, 3 hours post-dose on all study days and at the follow-up visit.

Safety assessments included scheduled monitoring of adverse events (AEs), vital sign measurements, 12-lead ECG measurements, physical examinations, and clinical laboratory testing (chemistry, hematology, and urinalysis).

Determine whether quantifiable concentrations of larazotide acetate are present in plasma following single oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects that are gluten-free and in remission
erial blood samples were collected for pharmacokinetic determinations at baseline and 2 and 3 hours post dose.

Pharmacokinetic samples were taken to determine whether quantifiable concentrations of larazotide acetate were present in plasma following single oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects.

Evaluate the effects of single doses of larazotide acetate on intestinal permeability ratios and zonulin levels
Intestinal permeability was measured each day following dosing. A gluten challenge was administered on Day 2.

Intestinal permeability was measured by administration of an oral sucrose, lactulose and mannitol solution followed by urine and serum collection to measure urinary lactulose and mannitol, and serum zonulin concentrations as biomarkers.

Secondary Endpoints

Anti-transglutaminase
6 weeks
Assess the safety and tolerability of larazotide acetate
Up to 8 weeks
To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole.
Up to 8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Larazotide acetate 1 mgEXPERIMENTALlarazotide acetate 1 mg capsules TID + 900 mg gluten capsules TID for 6 weeks
PlaceboPLACEBO_COMPARATORplacebo capsules TID + 900 mg gluten capsules TID for 6 weeks
Larazotide acetate 4 mgEXPERIMENTALlarazotide acetate capsules 4 mg TID
Larazotide acetate 8 mgEXPERIMENTALLarazotide acetate capsules 8 mg TID
Placebo + GlutenPLACEBO_COMPARATORplacebo TID + gluten 800 mg TID administered orally in capsules
Placebo + Gluten placeboPLACEBO_COMPARATORplacebo TID + gluten placebo TID administered orally in capsules
Larazotide acetate 8 mg + Gluten placeboOTHERSafety Control Arm. Larazotide acetate 8 mg TID + gluten placebo TID administered orally in capsules
Larazotide acetate 0.25 mg + GlutenACTIVE_COMPARATORLarazotide acetate 0.25 mg TID + gluten 800 mg TID administered orally in capsules
Larazotide acetate 1 mg + GlutenACTIVE_COMPARATORLarazotide acetate 1 mg TID + gluten 800 mg TID administered orally in capsules
Larazotide acetate 4 mg + GlutenACTIVE_COMPARATORLarazotide acetate 4 mg TID + gluten 800 mg TID administered orally in capsules
Larazotide acetate 8 mg + GlutenACTIVE_COMPARATORLarazotide acetate 8 mg TID + gluten 800 mg TID administered orally in capsules
Larazotide acetateEXPERIMENTALLarazotide acetate capsules: 12 mg QD x 3 days

Interventions

NameTypeDescription
Larazotide acetateDRUGgelatin capsule
PlaceboDRUGgelatin capsule
Gluten 900 mgDIETARY_SUPPLEMENTgelatin capsule
900 mg glutenDIETARY_SUPPLEMENTgelatin capsules
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Eligibility Criteria

Age Range18 Years to 72 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Male and female adults with biopsy proven celiac disease on a gluten-free diet for at least the past 6 months * Anti-Tissue Transglutaminase (anti-tTG) ≤ 10 EU. * BMI between 18.5 and 38, inclusive. Exclusion Criteria * Has chronic active GI disease other than celiac disease...

Countries:United StatesCanadaSpain
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Competitive Landscape -Celiac Disease 4 trials

CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY1PHASE2Amlitelimab
Forte Biosciences Inc.FBRX1PHASE2FB102
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA1PHASE2TEV-53408
Barinthus Biotherapeutics plc Sponsored ADRBRNS1EARLY_PHASE1VTP-1000
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