DelfaGLP-1 Atlas

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CompletedPhase 1

Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)

A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

13

Recruiting sites

—

Enrollment

64

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 IDNCT05292911
Org study IDALT-801-106

Timeline

Milestones

Study start2022-03-09actual
Study first posted2022-03-23actual
Primary completion2022-10-31actual
Study completion2022-10-31actual
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 to participate in this extension study, signed prior to the performance of any study procedures
•Receipt of 12 weeks of investigational product with completion of the procedures in Study ALT-801-105
•Women who are not pregnant or breastfeeding

Exclusion criteria

•Meets any of the exclusion criteria in Study ALT-801-105 at the time of study entry
•Development of any of the following conditions at any time during Study ALT-801-105:

1. Type 1 DM and/or insulin-dependent type 2 diabetes mellitus (T2DM), or uncontrolled T2DM requiring rescue therapy in study ALT-801-105

2. 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 to 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 to 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 to Day 85

MRI-PDFF, % change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fibrosis markers (Pro-C3)

Time frame:Baseline to 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 to Day 85

change from baseline, improvement

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.