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

Registration

Registration

NCT04561245

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

DOUBLE

Status

COMPLETED

Enrollment

100

Start

2020-11-10

Primary completion

2021-10-29

Lead sponsor

Altimmune, Inc.

Conditions

Obesity; Nonalcoholic Steatohepatitis

Interventions

DRUG:ALT-801; OTHER:Placebo

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

OTHER:Pemvidutide

Registered primary outcomes

• 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]