DelfaGLP-1 Atlas

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CompletedPhase 1

ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

15

Recruiting sites

—

Enrollment

95

actual

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT05006885
Org study IDALT-801-105

Timeline

Milestones

Study first posted2021-08-16actual
Study start2021-09-30actual
Primary completion2022-08-17actual
Study completion2022-08-17actual
Last update posted2023-07-27actual

Assets

Investigational agents

Pemvidutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Written informed consent signed prior to the performance of any study procedures
•Male or female volunteers, age 18 to 65 years, inclusive
•Overweight to obese (greater than or equal to BMI 28.0
•Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%
•If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (SGLT-2) therapy

Exclusion criteria

•Women who are pregnant or breastfeeding
•Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%
•History of pancreatitis or hypersensitivity reaction to GLP-1 analogues

Endpoints (6)

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

MASH / liver
2
Weight & body composition
1
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline and Day 85

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from baseline in hemoglobin A1c

Time frame:Baseline and Day 85

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Secondary/protocol endpoint

Change from baseline in liver fat fraction by MRI-PDFF

Time frame:Baseline and Day 85

MRI-PDFF, % change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fibrosis markers (Pro-C3)

Time frame:Baseline and Day 85

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)

Time frame:Baseline and Day 85

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

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

Time frame:Up to Day 110

Treatment-emergent AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.