GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

An Open-label Study of the Effect of ALT-801 on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin, Digoxin, and the Combined Oral Contraceptive Ethinylestradiol/Levonorgestrel in Healthy Volunteers

Lead sponsor

Altimmune, Inc.

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 28-40•Healthy volunteers

Primary endpoints

•AUC of metformin and atorvastatin/warfarin•AUC of ethinylestradiol and levonorgestrel in presence of steady state ALT-801 (AUC₀–∞, AUC₀–∞)

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 IDNCT04972396

Org study IDALT-801-103

Secondary IDALT-801Altimmune

Timeline

Milestones

Study first posted2021-07-22actual

Study start2021-09-15actual

Primary completion2022-05-15actual

Study completion2022-05-15actual

Last update posted2025-06-24actual

Assets

Investigational agents

Pemvidutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female healthy volunteers, age 18 to 55 years, inclusive

•Body mass index (BMI) 28.0- 40.0 kg/m2

•Able and willing to provide written informed consent prior to entry into the study

Exclusion criteria

•Women who are pregnant or breastfeeding

•History of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or HbA1c ≥ 6.5%

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

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.

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801

Time frame:Baseline and Day 36

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801

Time frame:Baseline and Day 43

AUC₀–∞

concentration, descriptive

componentsAUC₀–∞, AUC₀–∞

Secondary/protocol endpoint

Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin

Time frame:Day 36

Cmax

concentration, descriptive

Secondary/protocol endpoint

Cmax and Tmax of ethinylestradiol and levonorgestrel

Time frame:Day 43

Cmax

concentration, descriptive

componentsCmax, Tmax

Secondary/protocol endpoint

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

Time frame:Up to Day 77

Treatment-emergent AEs (any)

threshold achievement, event

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.