ALT-801 (Pemvidutide) 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

This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects.

The purpose of the study was to assess the safety and tolerability in healthy overweight and obese volunteers administered single or multiple repeated doses of ALT-801 (pemvidutide).

Study Overview

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

Detailed Description

This study had 2 parts. Part 1 involved single dose cohorts of ALT-801 (pemvidutide) or placebo taken as a subcutaneous (SC) injection and was approximately 36 days in duration. Part 2 involved multiple dose cohorts of ALT-801 (pemvidutide) or placebo taken once a week for 12 weeks as a SC injection and was approximately 116 days in duration. Each participant enrolled in only one part.

• 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

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)
• Non-smokers or ex-smokers (must have ceased smoking > 1 months prior to screening visit)
• 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 pancreatitis
• History of or acute significant GI disorder
• History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%
• History of clinically significant endocrine (eg, hypothyroidism), neurological, GI, cardiovascular (except controlled hypertension and hypercholesterolemia), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

• 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
• Blood pressure > 150/90 mmHg or heart rate > 100 beats per minute at screening and at Day -1
• Clinically significant laboratory abnormalities including:

Impaired renal function (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2) as estimated using the MDRD equation at screening:

1. GFR (mL/min/1.73 m²) = 175 × (SCr/88.4)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) (SI units), where SCr is standardized serum creatinine in SI units (µmol/L) and age is in years
2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values > 2 × upper normal limits
3. Calcitonin > 50 ng/L - Excessive alcohol consumption defined as >21 alcohol units per week for males and as >14 alcohol units per week for females (where 1 unit = half pint of beer, 25 mL of 40% spirit, or 125 mL of wine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALT-801 (Part 1); Single ascending dose (SAD) cohorts of ALT-801	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
Placebo Comparator: Placebo (Part 1); Single dose of placebo	Other: Placebo; Injected subcutaneously (SC)
Experimental: ALT-801 (Part 2); Multiple ascending dose (MAD) cohorts of ALT-801 administered once weekly for 12 weeks	Drug: ALT-801; Injected subcutaneously (SC); Other Names: Pemvidutide
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.
• Investigators: Study Director: Altimmune Chief Medical Officer, Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 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): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; NASH
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Liver Diseases; Overweight; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ALT-801-101; Pemvidutide (Other Identifier: Altimmune)

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