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

Phase 1

Completed

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: ALT-801; Other: Placebo

• Registration Number: NCT04561245
• Lead Sponsor: Altimmune, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-22
• Study First Posted: 2020-09-23
• Study Start: 2020-11-10
• Status Verified: 2021-07
• Primary Completion: 2021-10-23
• Study Completion: 2021-10-23
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALT-801 (Part 1)	ALT-801	Escalating doses of ALT-801 administered once
Placebo (Part 1)	Placebo	Placebo administered once
ALT-801 (Part 2)	ALT-801	Escalating doses of ALT-801 administered once weekly for 12 weeks
Placebo (Part 2)	Placebo	Placebo administered once weekly for 12 weeks

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Nucleus Networks; 🇦🇺 Herston, Queensland, Australia