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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04561245

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
ALT-801 in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ALT-801 in Healthy Overweight and Obese Volunteers
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH - Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - ALT-801
Other interventions - Placebo

Experimental: ALT-801 (Part 1) - Escalating doses of ALT-801 administered once

Placebo Comparator: Placebo (Part 1) - Placebo administered once

Experimental: ALT-801 (Part 2) - Escalating doses of ALT-801 administered once weekly for 6 weeks

Placebo Comparator: Placebo (Part 2) - Placebo administered once weekly for 6 weeks

Treatment: Drugs: ALT-801
Injected subcutaneously (SC)

Other interventions: Placebo
Injected subcutaneously (SC)

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42
Primary outcome [2] 0 0
Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801
Timepoint [2] 0 0
Baseline, Day 26
Primary outcome [3] 0 0
Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801
Timepoint [3] 0 0
Baseline to Day 26
Primary outcome [4] 0 0
Change in body weight
Timepoint [4] 0 0
Baseline to Week 6
Primary outcome [5] 0 0
Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)
Timepoint [5] 0 0
Baseline to Week 6

Key inclusion criteria
- Male or female healthy volunteers, age 18 to 70 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
Minimum age
18 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Networks - Herston
Recruitment postcode(s) [1] 0 0
- Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Altimmune, Inc.

Ethics approval
Ethics application status

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 6 doses of ALT-801,
once a week for 6 weeks, as a SC injection and will be approximately 74 days in duration.
Each participant will enroll in only one part.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Altimmune CTM
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04561245