Non-Alcoholic Steatohepatitis (NASH)Phase 2IMPACTNCT05989711
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study testing Pemvidutide in people with Non-Alcoholic Steatohepatitis (NASH), run by Altimmune, Inc. at 40 sites in 3 countries.
Trial summary
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Steatohepatitis (NASH)
- What is being tested?
- Pemvidutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 40 sitesin 3 countries
- Study dates
- 27 Jul 2023to 25 Nov 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or female 18-75 years
- Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening
- A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2])
- NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation
- Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment
Show all 10Show fewer
- BMI ≥ 27.0 kg/m2
- Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening
- Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)
- Liver fat content by MRI-PDFF ≥ 8%
Who cannot join
- Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening
- History or clinical evidence of Type 1 diabetes mellitus
- Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia
- Liver conditions:
- History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites
- Documented causes of chronic liver disease other than NASH
- ALT or AST laboratory values > 5 × ULN
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States29 sites
Altimmune Clinical Study Site
Austin, Texas, 73301
Altimmune Clinical Study Site
Bastrop, Louisiana, 78602
Altimmune Clinical Study Site
Bellaire, Texas, 77401
Altimmune Clinical Study Site
Bradenton, Florida, 34201
Altimmune Clinical Study Site
Chandler, Arizona, 85224
Altimmune Clinical Study Site
Clarksville, Tennessee, 37040
Altimmune Clinical Study Site
Dalton, Georgia, 30720
Altimmune Clinical Study Site
Edinburg, Texas, 78539
Altimmune Clinical Study Site
Edinburg, Texas, 78540
Altimmune Clinical Study Site
Englewood, Colorado, 80110
Altimmune Clinical Study Site
Fort Myers, Florida, 33912
Altimmune Clinical Study Site
Georgetown, Texas, 78626
Altimmune Clinical Study Site
Germantown, Tennessee, 38138
Altimmune Clinical Study Site
Hialeah Gardens, Florida, 33018
Altimmune Clinical Study Site
Houston, Texas, 77036
Altimmune Clinical Study Site
Marietta, Georgia, 30006
Altimmune Clinical Study Site
Miami Lakes, Florida, 33014
Altimmune Clinical Study Site
North Hollywood, California, 33019
Altimmune Clinical Study Site
Panorama City, California, 91402
Altimmune Clinical Study Site
Peoria, Arizona, 85345
Altimmune Clinical Study Site
Port Orange, Florida, 32123
Altimmune Clinical Study Site
San Antonio, Texas, 78201
Altimmune Clinical Study Site
San Antonio, Texas, 78204
Altimmune Clinical Study Site
Sarasota, Florida, 34240
Altimmune Clinical Study Site
Shreveport, Louisiana, 71101
Altimmune Clinical Study Site
Tucson, Arizona, 85701
Altimmune Clinial Study Site
Tucson, Arizona, 85704
Altimmune Clinical Study Site
West Jordan, Utah, 84081
Altimmune Clinical Study Site
West Palm Beach, Florida, 33401
Australia10 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victory, 3128
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Hospital
Clayton, Victory, 3168
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Austin Health
Heidelberg, Victoria, 3084
Liverpool Hospital
Liverpool, New South Wales, 2170
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Princess Alexandra Hospital/ Translational Research Institute
Woolloongabba, Queensland, 4102
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
Read the detailed description
A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Being tested
- Pemvidutide, Placebo
- 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
Administered once weekly by subcutaneous injection
PlaceboDrug
Administered once weekly by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Pemvidutide 1.2 mg | Experimental | Not described Receives: Drug: Pemvidutide |
| Pemvidutide 1.8 mg | Experimental | Not described Receives: Drug: Pemvidutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
Measured: 24 weeks
Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)
Measured: 24 weeks
Incidence of Treatment Emergent Adverse Events
Measured: 52 weeks
Secondary outcomes (13)
Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks
Measured: 24 weeks
Relative change (%) in liver fat content by MRI-PDFF
Measured: 24 weeks and 48 weeks
Absolute change in MRI-based corrected T1 (cT1) imaging
Measured: 24 weeks and 48 weeks
Absolute change in alanine aminotransferase (ALT)
Measured: 24 weeks and 48 weeks
Absolute change in Enhanced Liver Fibrosis (ELF) score
Measured: 24 weeks and 48 weeks
Absolute change in Fibroscan-AST (FAST) score
Measured: 24 weeks and 48 weeks
Relative (%) change in body weight
Measured: 24 weeks and 48 weeks
Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Measured: 24 weeks and 48 weeks
Change in HbA1c (%)
Measured: 24 weeks and 48 weeks
Change in glucose (mg/dL)
Measured: 24 weeks and 48 weeks
Change in systolic and diastolic blood pressure (mmHg)
Measured: 24 weeks and 48 weeks
Change in heart rate (beats per minute)
Measured: 24 weeks and 48 weeks
The number of subjects with treatment emergent adverse events
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start27 Jul 2023
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
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 Steatohepatitis (NASH)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 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
- NCT05989711
- Sponsor's protocol ID
- ALT- 801-203
- Acronym
- IMPACT
- Status last verified
- May 2026
- First submitted
- 24 Jul 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Noureddin M, Harrison SA, Loomba R, Alkhouri N, Chalasani N, Sheikh MY, Tomah S, Gutierrez JA, Urbina S, Suschak JJ, Brown R, Odili O, Yang J, Keeton S, Neff G, Mena E, Roberts MS, Browne SK, Harris MS. Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study. Lancet. 2025 Dec 6;406(10520):2644-2655. doi: 10.1016/S0140-6736(25)02114-2. Epub 2025 Nov 11.
PubMed 41237796
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT05989711
- Acronym / sponsor ID
- IMPACT / ALT- 801-203
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 14 Aug 2023 (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.
Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.
Detailed description
A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-blind, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Pemvidutide 1.2 mg | Experimental | Drug: Pemvidutide |
| Pemvidutide 1.8 mg | Experimental | Drug: Pemvidutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent
- Male or female 18-75 years
- Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening
- Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment
- BMI ≥ 27.0 kg/m2
Key exclusion criteria (7 listed)
- Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening
- History or clinical evidence of Type 1 diabetes mellitus
- Hemoglobin A1c (HbA1c) > 9.5% or clinically significant persistent hyperglycemia
- Liver conditions:
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 |
|---|---|---|
| PemvidutideAdministered once weekly by subcutaneous injection | Drug | Pemvidutide 1.2 mg, Pemvidutide 1.8 mg |
| PlaceboAdministered once weekly by subcutaneous injection | Drug | Placebo |
Primary outcome
Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis
Time frame: 24 weeks
Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)
Time frame: 24 weeks
Incidence of Treatment Emergent Adverse Events
Time frame: 52 weeks
13 secondary outcomes
Proportion of subjects achieving the composite of both NASH resolution and at least 1 stage improvement of liver fibrosis at 24 weeks
Time frame: 24 weeks
Relative change (%) in liver fat content by MRI-PDFF
Time frame: 24 weeks and 48 weeks
Absolute change in MRI-based corrected T1 (cT1) imaging
Time frame: 24 weeks and 48 weeks
Absolute change in alanine aminotransferase (ALT)
Time frame: 24 weeks and 48 weeks
Absolute change in Enhanced Liver Fibrosis (ELF) score
Time frame: 24 weeks and 48 weeks
Absolute change in Fibroscan-AST (FAST) score
Time frame: 24 weeks and 48 weeks
Relative (%) change in body weight
Time frame: 24 weeks and 48 weeks
Absolute changes in fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides)
Time frame: 24 weeks and 48 weeks
Change in HbA1c (%)
Time frame: 24 weeks and 48 weeks
Change in glucose (mg/dL)
Time frame: 24 weeks and 48 weeks
Change in systolic and diastolic blood pressure (mmHg)
Time frame: 24 weeks and 48 weeks
Change in heart rate (beats per minute)
Time frame: 24 weeks and 48 weeks
The number of subjects with treatment emergent adverse events
Time frame: 48 weeks
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 18 May 2026.
- Derived from this study: PubMed 41237796Noureddin M, Harrison SA, Loomba R, Alkhouri N, Chalasani N, Sheikh MY, Tomah S, Gutierrez JA, Urbina S, Suschak JJ, Brown R, Odili O, Yang J, Keeton S, Neff G, Mena E, Roberts MS, Browne SK, Harris MS. Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study. Lancet. 2025 Dec 6;406(10520):2644-2655. doi: 10.1016/S0140-6736(25)02114-2. Epub 2025 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemvidutide in people with Non-Alcoholic Steatohepatitis (NASH), run by Altimmune, Inc. at 40 sites in 3 countries.
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 10 inclusion and 7 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 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Australia, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 NCT05989711, 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 18 May 2026.