NASH - Nonalcoholic SteatohepatitisPhase 1NCT04972396
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
A Phase 1 study testing Pemvidutide, Metformin and Atorvastatin in people with NASH - Nonalcoholic Steatohepatitis, run by Altimmune, Inc. at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Pemvidutide, Metformin and Atorvastatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesAustralia
- Study dates
- 15 Sep 2021to 15 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
CMAX Clinical Research
Adelaide, South Australia
Nucleus Network
Brisbane
About this study
Official title: 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
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.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- Pemvidutide, Metformin, Atorvastatin, Warfarin, Digoxin
- Keywords
- NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemvidutideDrug
Also called ALT-801
Injected subcutaneously (SC)
MetforminDrug
Taken by mouth (PO)
AtorvastatinDrug
Taken by mouth (PO)
WarfarinDrug
Taken by mouth (PO)
DigoxinDrug
Taken by mouth (PO)
Ethinylestradiol and LevonorgestrelDrug
Taken by mouth (PO)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Metformin and Atorvastatin with and without Pemvidutide | Experimental | In Period 1, subjects received metformin 500 mg BID on Days 1 and 2, single doses of metformin 500 mg and atorvastatin 40 mg on Day 3, and a single dose of pemvidutide 0.6 mg on Day 8.
In Period 2, subjects received single doses of pemvidutide1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, metformin 500 mg BID on Days 34 and 35, and pemvidutide 1.8 mg on Day 36 immediately followed by oral metformin 500 mg and atorvastatin 40 mg. Receives: Drug: Pemvidutide; Drug: Metformin; Drug: Atorvastatin |
| Part 2 Warfarin and Digoxin with and without Pemvidutide | Experimental | In Period 1, subjects received single doses of warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 1, and a single dose of pemvidutide 0.6 mg on Day 8.
In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, and pemvidutide1.8 mg immediately followed by warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 36. Receives: Drug: Pemvidutide; Drug: Warfarin; Drug: Digoxin |
| Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide | Experimental | In Period 1, subjects received a combined oral contraceptive (COC) consisting of 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel once daily on Days 1 through 9 and a single dose of pemvidutide 0.6 mg on Day 15.
In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 22 and 1.8 mg on Days 29 and 36. Subjects also received COC once daily on Days 35 through 42 and a single dose of pemvidutide 1.8 mg followed immediately by a single dose of COC on Day 43. Receives: Drug: Pemvidutide; Drug: Ethinylestradiol and Levonorgestrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801
Measured: Baseline and Day 36
Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801
Measured: Baseline and Day 43
Secondary outcomes (3)
Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin
Measured: Day 36
Cmax and Tmax of ethinylestradiol and levonorgestrel
Measured: Day 43
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start15 Sep 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972396
- Sponsor's protocol ID
- ALT-801-103
- Other IDs
- Pemvidutide, ALT-801
- Status last verified
- Jun 2025
- First submitted
- 14 Jul 2021
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04972396
- Acronym / sponsor ID
- ALT-801-103
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- NASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Metformin and Atorvastatin with and without Pemvidutide | Experimental | Drug: Pemvidutide, Drug: Metformin, Drug: AtorvastatinIn Period 1, subjects received metformin 500 mg BID on Days 1 and 2, single doses of metformin 500 mg and atorvastatin 40 mg on Day 3, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, metformin 500 mg BID on Days 34 and 35, and pemvidutide 1.8 mg on Day 36 immediately followed by oral metformin 500 mg and atorvastatin 40 mg. |
| Part 2 Warfarin and Digoxin with and without Pemvidutide | Experimental | Drug: Pemvidutide, Drug: Warfarin, Drug: DigoxinIn Period 1, subjects received single doses of warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 1, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, and pemvidutide1.8 mg immediately followed by warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 36. |
| Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide | Experimental | Drug: Pemvidutide, Drug: Ethinylestradiol and LevonorgestrelIn Period 1, subjects received a combined oral contraceptive (COC) consisting of 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel once daily on Days 1 through 9 and a single dose of pemvidutide 0.6 mg on Day 15. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 22 and 1.8 mg on Days 29 and 36. Subjects also received COC once daily on Days 35 through 42 and a single dose of pemvidutide 1.8 mg followed immediately by a single dose of COC on Day 43. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemvidutideAlso: ALT-801Injected subcutaneously (SC) | Drug | Part 1 Metformin and Atorvastatin with and without Pemvidutide, Part 2 Warfarin and Digoxin with and without Pemvidutide, Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide |
| MetforminTaken by mouth (PO) | Drug | Part 1 Metformin and Atorvastatin with and without Pemvidutide |
| AtorvastatinTaken by mouth (PO) | Drug | Part 1 Metformin and Atorvastatin with and without Pemvidutide |
| WarfarinTaken by mouth (PO) | Drug | Part 2 Warfarin and Digoxin with and without Pemvidutide |
| DigoxinTaken by mouth (PO) | Drug | Part 2 Warfarin and Digoxin with and without Pemvidutide |
| Ethinylestradiol and LevonorgestrelTaken by mouth (PO) | Drug | Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide |
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemvidutide, Metformin and Atorvastatin in people with NASH - Nonalcoholic Steatohepatitis, run by Altimmune, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.