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

• ClinicalTrials.gov Identifier: NCT04561245
• Recruitment Status: Completed
• First Posted: September 23, 2020
• Last Update Posted: November 10, 2021
• Sponsor: Altimmune, Inc.
• Information provided by (Responsible Party): Altimmune, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
NASH - Nonalcoholic Steatohepatitis	Drug: ALT-801; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers
• Actual Study Start Date: November 10, 2020
• Actual Primary Completion Date: October 23, 2021
• Actual Study Completion Date: October 23, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Australia, Queensland

Nucleus Networks

Herston, Queensland, Australia

Sponsors and Collaborators

Altimmune, Inc.

More Information

• Responsible Party: Altimmune, Inc.
• ClinicalTrials.gov Identifier: NCT04561245
• Other Study ID Numbers: ALT-801-101
• First Posted: September 23, 2020
• Last Update Posted: November 10, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Altimmune, Inc.:

NASH; Nonalcoholic Steatohepatitis

Additional relevant MeSH terms:

Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight; Body Weight; Liver Diseases; Digestive System Diseases