ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of ALT-801. This study has 2 parts. Part 1 involves a single dose of ALT-801 taken as a subcutaneous (SC) injection and will be approximately 36 days in duration. Part 2 involves 12 doses of ALT-801, once a week for 12 weeks, as a SC injection and will be approximately 116 days in duration. Each participant will enroll in only one part.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers

Conditions
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NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment
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* Drug: ALT-801
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female healthy volunteers, age 18 to 60 years, inclusive Overweight to obese (BMI 25.0 - 40.0 kg/m2) MRI-PDFF≥ 10% (Part 2 only) Subjects must otherwise be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at screening, and/or before administration of the initial dose of study medication Ability and willingness to attend the necessary visits to the study center Written informed consent signed prior to entry into the study Exclusion Criteria: Women who are pregnant or breastfeeding History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5% History of neoplastic disease, or personal or family history of multiple endocrine neoplasia or medullary cancer of the thyroid, with the following exceptions: Adequately treated non-melanomatous skin carcinoma Female with a history of benign cervical neoplasia if the subject has been compliant with surveillance and treatment as recommended by her physician Mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study Clinically significant laboratory abnormalities including: a. Impaired renal function Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALT-801 (Part 1)<br>Escalating doses of ALT-801 administered once | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>|
| Placebo Comparator: Placebo (Part 1)<br>Placebo administered once | Other: Placebo<br>* Injected subcutaneously (SC)<br>|
| Experimental: ALT-801 (Part 2)<br>Escalating doses of ALT-801 administered once weekly for 12 weeks | Drug: ALT-801<br>* Injected subcutaneously (SC)<br>|
| Placebo Comparator: Placebo (Part 2)<br>Placebo administered once weekly for 12 weeks | Other: Placebo<br>* Injected subcutaneously (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) |  | Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42 | 
| Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801 |  | Baseline, Day 26 | 
| Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801 |  | Baseline to Day 26 | 
| Change in body weight |  | Baseline to Week 6 | 
| Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF) |  | Baseline to Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NASH, Nonalcoholic Steatohepatitis