GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Tolerability, Pharmacodynamics and Pharmacokinetics of ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

—

Primary endpoints

•Treatment-emergent AEs (any)•Changes from baseline in area under the curve of serum glucose, C-peptide•HOMA-IR (insulin sensitivity)

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 IDNCT05134662

Org study IDALT-801-104

Timeline

Milestones

Study first posted2021-11-26actual

Study start2022-02-01actual

Primary completion2023-02-03actual

Study completion2023-03-09actual

Last update posted2025-06-24actual

Assets

Investigational agents

Pemvidutide

Study populations

Who this study enrolls

Obesity / 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 (BMI >/=28.0 kg/m2)

•Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination of (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

•Female subjects of childbearing potential who are not pregnant or breastfeeding, do not plan to become pregnant during the study, and agree to use effective birth control

Exclusion criteria

•Type 1 diabetes mellitus (DM) and/or insulin-dependent T2DM, or uncontrolled T2DM defined as hemoglobin A1c (HbA1c) ≥ 9.5% or C-peptide ≤ 8 ng/mL

•History of acute or chronic pancreatitis or hypersensitivity reaction to GLP-1 analogues

Endpoints (8)

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

Glycemic / diabetes

Safety / tolerability / PK

Patient-reported / QoL

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint/low confidence

Changes from baseline in area under the curve of serum glucose, C-peptide, and insulin

Time frame:Baseline to Day 85

change from baseline, improvement

Primary/protocol endpoint

Changes from baseline in fasting serum glucose and insulin as measured by Homeostasis Model Assessment for Insulin Resistance 2 (HOMA-IR2)

Time frame:Baseline to Day 85

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting serum glucose

Time frame:Baseline to Day 85

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in hemoglobin A1c (HbA1c)

Time frame:Baseline to Day 85

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

1 endpoint

Other/protocol endpoint

Changes in quality of life questionnaires compared to baseline

Time frame:Baseline to Day 85

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:Up to Day 110

Treatment-emergent AEs (any)

event count, event

Other/protocol endpoint

ALT-801 concentrations

Time frame:Baseline to Day 110

Plasma concentration (steady state)

concentration, descriptive

Other/protocol endpoint

Change from baseline metformin concentrations

Time frame:Baseline to Day 85

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.