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NCT04972396·Phase 1·INTERVENTIONAL

Pemvidutide (ALT-801) DDI Study in Healthy Volunteers

PemvidutideOtherCompleted

Status

Completed

Phase

Phase 1

Enrollment

40

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is a Phase 1, open-label, drug-drug interaction (DDI) study of pemvidutide (ALT-801) under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of pemvidutide on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (COC) ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below. Each part will have 2 periods in a fixed sequence, where the first period is without pemvidutide administration and the second is with pemvidutide at steady state.

Interventions

Treatment arms and agents.

DRUG

Pemvidutide

Injected subcutaneously (SC)

DRUG

Metformin

Taken by mouth (PO)

DRUG

Atorvastatin

Taken by mouth (PO)

DRUG

Warfarin

Taken by mouth (PO)

DRUG

Digoxin

Taken by mouth (PO)

DRUG

Ethinylestradiol and Levonorgestrel

Taken by mouth (PO)

Timeline

From registration to results.

  1. First posted

    Jul 22, 2021

  2. Study start

    Sep 15, 2021

  3. Primary completion

    May 15, 2022

  4. Study completion

    May 15, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Jun 24, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

Secondary outcomes

Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin

Time frame · Day 36

Cmax and Tmax of ethinylestradiol and levonorgestrel

Time frame · Day 43

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

Time frame · Up to Day 77

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
ALL
Healthy volunteers
Yes

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

Study locations

2 registered sites.

Australia. Showing up to 24 locations stored in the fast local snapshot.

CMAX Clinical Research

Adelaide, South Australia, Australia

Nucleus Network

Brisbane, Australia

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsPemvidutide trial dashboard →