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

NCT ID: NCT04561245

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2021-10-29

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).

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.

Conditions

Obesity; Nonalcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ALT-801 (Part 1)

Single ascending dose (SAD) cohorts of ALT-801

Group Type: EXPERIMENTAL

ALT-801

Intervention Type: DRUG

Injected subcutaneously (SC)

Placebo (Part 1)

Single dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Injected subcutaneously (SC)

ALT-801 (Part 2)

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

Group Type: EXPERIMENTAL

ALT-801

Intervention Type: DRUG

Injected subcutaneously (SC)

Placebo (Part 2)

Placebo administered once weekly for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Injected subcutaneously (SC)

Interventions

ALT-801

Injected subcutaneously (SC)

Intervention Type: DRUG

Placebo

Injected subcutaneously (SC)

Intervention Type: OTHER

Other Intervention Names

Pemvidutide

Eligibility 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)
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Altimmune, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Altimmune Chief Medical Officer

Role: STUDY_DIRECTOR

Altimmune, Inc.

Locations

Nucleus Networks

Herston, Queensland, Australia

Countries

Australia

Other Identifiers

Pemvidutide

Identifier Type: OTHER

Identifier Source: secondary_id

ALT-801-101

Identifier Type: -

Identifier Source: org_study_id