Non-Alcoholic Fatty Liver DiseasePhase 1NCT05006885
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
A Phase 1 study testing ALT-801 in people with Non-Alcoholic Fatty Liver Disease, run by Altimmune, Inc. at 15 sites in United States.
Trial summary
The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- ALT-801
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 15 sitesUnited States
- Study dates
- 30 Sep 2021to 17 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (greater than or equal to BMI 28.0
- Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%
- If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (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
Who cannot join
- Women who are pregnant or breastfeeding
- Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%
- History of pancreatitis or hypersensitivity reaction to GLP-1 analogues
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Accelemed Research Institute
Austin, Texas, 78745
Pinnacle Research
Austin, Texas, 78757
South Texas Research Institute
Brownsville, Texas, 78520
South Texas Research Institute
Edinburg, Texas, 78539
Wake Research CRCN
Las Vegas, Nevada, 89106
Panax Clinical Research
Miami Lakes, Florida, 33014
Catalina Research Institute
Montclair, California, 91763
Clinical Trials Research
Sacramento, California, 95648
Cognitive Clinical Trials
Salt Lake City, Utah, 84117
Diagnostics Research Group
San Antonio, Texas, 78229
Pinnacle Research
San Antonio, Texas, 78229
Covenant Research and Clinics
Sarasota, Florida, 34240
Headlands Research Sarasota
Sarasota, Florida, 34243
Headlands Research Scottsdale
Scottsdale, Arizona, 85260
QLMC
Tucson, Arizona, 85712
About this study
Official title: A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease
The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).
Read the detailed description
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- ALT-801, Placebo
- Keywords
- Obese, Overweight
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT-801Drug
Also called Pemvidutide
Injected subcutaneously (SC)
PlaceboOther
Injected subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| ALT-801 Dose Level 1 | Experimental | Administered once a week for 12 weeks Receives: Drug: ALT-801 |
| ALT-801 Dose Level 2 | Experimental | Administered once a week for 12 weeks Receives: Drug: ALT-801 |
| ALT-801 Dose Level 3 | Experimental | Administered once a week for 12 weeks Receives: Drug: ALT-801 |
| Placebo | Placebo comparator | Administered once a week for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Number of participants with 1 or more TEAEs up to Day 110
Measured: Up to Day 110
Secondary outcomes (5)
Change from baseline in liver fat fraction by MRI-PDFF
Change in liver fat fraction by MRI-PDFF from Baseline to Day 85
Measured: Baseline and Day 85
Change from baseline in body weight
Change in body weight from Baseline to Day 85
Measured: Baseline and Day 85
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Change from in lipid metabolism (TC, HDL, LDL) from Baseline to Day 85
Measured: Baseline and Day 85
Change from baseline in hemoglobin A1c
Change in hemoglobin A1c from Baseline to Day 85
Measured: Baseline and Day 85
Change from baseline in fibrosis markers (Pro-C3)
Change in fibrosis markers (Pro-C3) from Baseline to Day 85
Measured: Baseline and Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start30 Sep 2021
- Primary completion17 Aug 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah K Browne, MD, Study director, Altimmune, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006885
- Sponsor's protocol ID
- ALT-801-105
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Harrison SA, Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Roberts MS, Harris MS. Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. J Hepatol. 2025 Jan;82(1):7-17. doi: 10.1016/j.jhep.2024.07.006. Epub 2024 Jul 11.
PubMed 39002641
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05006885
- Acronym / sponsor ID
- ALT-801-105
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Obese, Overweight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 16 Aug 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.
The purpose of the study is to assess the safety and tolerability of ALT-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (NAFLD).
Detailed description
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of ALT-801 the safety of ALT-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (BMI 28.0-45.0 kg/m2) subjects with NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALT-801 Dose Level 1 | Experimental | Drug: ALT-801Administered once a week for 12 weeks |
| ALT-801 Dose Level 2 | Experimental | Drug: ALT-801Administered once a week for 12 weeks |
| ALT-801 Dose Level 3 | Experimental | Drug: ALT-801Administered once a week for 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboAdministered once a week for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (greater than or equal to BMI 28.0
- Magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥ 10%
- If subject has Type 2 diabetes mellitus (T2DM), on stable regimen, for at least 3 months prior to screening, of any combination (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
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding
- Type 1 DM and/or insulin-dependent T2DM, or uncontrolled T2DM defined as HbA1c ≥ 9.5%
- 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 |
|---|---|---|
| ALT-801Also: PemvidutideInjected subcutaneously (SC) | Drug | ALT-801 Dose Level 1, ALT-801 Dose Level 2, ALT-801 Dose Level 3 |
| PlaceboInjected subcutaneously (SC) | Other | Placebo |
Primary outcome
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 110
Number of participants with 1 or more TEAEs up to Day 110
5 secondary outcomes
Change from baseline in liver fat fraction by MRI-PDFF
Time frame: Baseline and Day 85
Change from baseline in body weight
Time frame: Baseline and Day 85
Change from baseline in lipid metabolism (total cholesterol, HDL cholesterol, LDL cholesterol, lipoprotein fractions)
Time frame: Baseline and Day 85
Change from baseline in hemoglobin A1c
Time frame: Baseline and Day 85
Change from baseline in fibrosis markers (Pro-C3)
Time frame: Baseline and Day 85
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 27 Jul 2023.
- Derived from this study: PubMed 39002641Harrison SA, Browne SK, Suschak JJ, Tomah S, Gutierrez JA, Yang J, Roberts MS, Harris MS. Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. J Hepatol. 2025 Jan;82(1):7-17. doi: 10.1016/j.jhep.2024.07.006. Epub 2024 Jul 11.
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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.
Sarah K Browne, MD study director
Altimmune, Inc.
15 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 ALT-801 in people with Non-Alcoholic Fatty Liver Disease, run by Altimmune, Inc. at 15 sites in United States.
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 5 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Day 110). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006885, which also lists 1 linked publication.
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 27 Jul 2023.