DelfaGLP-1 Atlas

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CompletedPhase 1

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

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

100

actual

Study population

Healthy volunteers, MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criteria

•BMI 25-40•Healthy volunteers

Primary endpoints

•Treatment-emergent AEs (any)•Cmax of ALT-801•Area Under the Concentration (AUC)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04561245
Org study IDALT-801-101
Secondary IDPemvidutideAltimmune

Timeline

Milestones

Study first posted2020-09-23actual
Study start2020-11-10actual
Primary completion2021-10-29actual
Study completion2021-10-29actual
Last update posted2025-06-24actual

Assets

Investigational agents

Pemvidutide

Study populations

Who this study enrolls

Healthy volunteersMASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersAccepted

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)

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
3
Weight & body composition
1
MASH / liver
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

Change in body weight

Time frame:Baseline to Week 6

Body weight, absolute change (kg)

change from baseline, improvement

MASH / liver

1 endpoint
Primary/protocol endpoint

Pharmacodynamic (PD): Change from baseline in magnetic resonance derived proton density fat fraction (MRI-PDFF)

Time frame:Baseline to Week 6

MRI-PDFF, % change

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)

Time frame:Part 1 SAD Cohorts: up to Day 26; Part 2 MAD Cohorts: up to Day 42

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Pharmacokinetic (PK): Maximum observed concentration (Cmax) of ALT-801

Time frame:Baseline, Day 26

Cmax

concentration, descriptive

Primary/protocol endpoint/low confidence

Pharmacokinetic (PK): Area Under the Concentration (AUC) vs Time Curve of ALT-801

Time frame:Baseline to Day 26

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.