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

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

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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: ALT-801; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia
      • Nucleus Networks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

  1. Adequately treated non-melanomatous skin carcinoma
  2. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ALT-801 (Part 1); Escalating doses of ALT-801 administered once	Drug: ALT-801; Injected subcutaneously (SC)
PLACEBO_COMPARATOR: Placebo (Part 1); Placebo administered once	Other: Placebo; Injected subcutaneously (SC)
EXPERIMENTAL: ALT-801 (Part 2); Escalating doses of ALT-801 administered once weekly for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC)
PLACEBO_COMPARATOR: Placebo (Part 2); Placebo administered once weekly for 12 weeks	Other: Placebo; Injected subcutaneously (SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2020
• Primary Completion (ACTUAL): October 23, 2021
• Study Completion (ACTUAL): October 23, 2021

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (ACTUAL): September 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Nonalcoholic Steatohepatitis; NASH
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Body Weight; Fatty Liver; Overweight; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ALT-801-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No