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

NCT04561245 | Completed Phase 1

• 2 other identifiers: ALT-801-101Pemvidutide
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity; Nonalcoholic Steatohepatitis

Keywords

NASH; Obesity

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

ALT-801 (Part 1)

EXPERIMENTAL

Single ascending dose (SAD) cohorts of ALT-801

Drug: ALT-801

Placebo (Part 1)

PLACEBO COMPARATOR

Single dose of placebo

Other: Placebo

ALT-801 (Part 2)

EXPERIMENTAL

Multiple ascending dose (MAD) cohorts of ALT-801 administered once weekly for 12 weeks

Drug: ALT-801

Placebo (Part 2)

PLACEBO COMPARATOR

Placebo administered once weekly for 12 weeks

Other: Placebo

Interventions

ALT-801 DRUG

Injected subcutaneously (SC)

Also known as: Pemvidutide

ALT-801 (Part 1); ALT-801 (Part 2)

Placebo OTHER

Injected subcutaneously (SC)

Placebo (Part 1); Placebo (Part 2)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Adequately treated non-melanomatous skin carcinoma
• 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:
• 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
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values \> 2 × upper normal limits
• 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)

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (1)

Nucleus Networks

Herston, Queensland, Australia

Location

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease

Interventions

ALT-801

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Altimmune Chief Medical Officer

  Altimmune, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 23, 2020
• Study Start: November 10, 2020
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)