Metabolic Dysfunction-Associated Steatohepatitis (MASH)Phase 3PERFORMANCT07795164
Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH
A Phase 3 study testing Pemvidutide in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Altimmune, Inc. at 9 sites in United States.
Trial summary
Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- 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
- 1,800 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Jul 2026to Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- All subjects:
- No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable)
- Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2
- Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome
- Subject agrees to have liver biopsy(ies) as required per protocol
- Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening
- Cohort 2 - Presumed F2/F3 MASH based on noninvasive testing
Who cannot join
- Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C
- Uncontrolled T2D or clinically significant persistent hyperglycemia
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Altimmune Clinical Study Site
Fountain Valley, California, 92708
- Recruiting
Altimmune Clinical Study Site
Fresno, California, 93720
- Recruiting
Altimmune Clinical Study Site
Gardena, California, 90247
- Recruiting
Altimmune Clinical Study Site
Long Beach, California, 90815
- Recruiting
Altimmune Clinical Study Site
Miami, Florida, 33173
- Recruiting
Altimmune Clinical Study Site
North Little Rock, Arkansas, 72117
- Recruiting
Altimmune Clinical Study Site
Ocala, Florida, 34471
- Recruiting
Altimmune Clinical Study Site
Springboro, Ohio, 45066
- Recruiting
Altimmune Clinical Study Site
Westlake, Ohio, 44145
About this study
Official title: A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.
- Being tested
- Pemvidutide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemvidutideDrug
Pemvidutide SC Injection
PlaceboOther
Placebo SC Injection
| Study group | Role | What they receive |
|---|---|---|
| Pemvidutide 1.8 mg | Experimental | Not described Receives: Drug: Pemvidutide |
| Pemvidutide 2.4 mg | Experimental | Not described Receives: Drug: Pemvidutide |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome Event
Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause
Measured: Baseline through end of study (approximately Month 60)
Histological Response: MASH resolution
Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network [CRN] classification) without worsening of fibrosis
Measured: Baseline through Week 52
Histological Response: Fibrosis improvement
Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH
Measured: Baseline through Week 52
Secondary outcomes (11)
Histologic Response: Proportion of subjects achieving both MASH resolution (according to NASH CRN classification) without worsening of fibrosis and ≥ 1 stage improvement in liver fibrosis without worsening of MASH
Measured: Baseline through Week 52
HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis
Measured: Baseline through Week 52
Anthropometric parameters: Relative (%) change from baseline in body weight (kg)
Measured: Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)
Measured: Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)
Measured: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in alanine aminotransferase (ALT; U/L)
Measured: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Measured: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Relative (%) change from baseline in vibration controlled transient elastography (VCTE; kPa) by Fibroscan
Measured: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.
Measured: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in Short-form 36 (SF-36) summary scores.
Measured: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH) domain scores.
Measured: Baseline through End of Study (approximately Month 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795164
- Sponsor's protocol ID
- ALT-801-301
- Acronym
- PERFORMA
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- ClinicalTrials.gov ID
- NCT07795164
- Acronym / sponsor ID
- PERFORMA / ALT-801-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 31 Aug 2026 (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.
Phase 3, multicenter, multinational, 2-cohort, randomized, double-blind, placebo controlled, parallel-group pivotal study to evaluate the efficacy, safety, and clinical outcomes of pemvidutide treatment in subjects with noncirrhotic (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH). Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pemvidutide 1.8 mg | Experimental | Drug: Pemvidutide |
| Pemvidutide 2.4 mg | Experimental | Drug: Pemvidutide |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- No significant changes in body weight (±5%) and not participating in a structured weight loss program for the 3 months prior to screening (or since the historical biopsy, if applicable)
- Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2
- Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome
- Subject agrees to have liver biopsy(ies) as required per protocol
- Cohort 1 - Histologic diagnosis of F2/F3 MASH based on liver biopsy during screening or historical biopsy within 6 months before screening
Key exclusion criteria (2 listed)
- Cirrhosis (F4); portal hypertension or hepatic decompensation; acute or chronic liver disease other than MASH; liver function tests (ALT, AST; alkaline phosphatase; total bilirubin; INR; and platelet count) outside of acceptable ranges; positive HBsAg; active hepatitis C
- Uncontrolled T2D or clinically significant persistent hyperglycemia
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 |
|---|---|---|
| PemvidutidePemvidutide SC Injection | Drug | Pemvidutide 1.8 mg, Pemvidutide 2.4 mg |
| PlaceboPlacebo SC Injection | Other | Placebo |
Primary outcome
Clinical Outcome Event
Time frame: Baseline through end of study (approximately Month 60)
Time to first occurrence of any of the following events through the end of the study: Histologic progression to cirrhosis (F4) on liver biopsy; Liver related events; Liver transplantation; or Death due to any cause
Histological Response: MASH resolution
Time frame: Baseline through Week 52
Proportion of subjects achieving MASH resolution (according to NASH Clinical Research Network [CRN] classification) without worsening of fibrosis
Histological Response: Fibrosis improvement
Time frame: Baseline through Week 52
Proportion of subjects achieving ≥ 1 stage improvement in liver fibrosis according to the NASH CRN fibrosis staging system without worsening of MASH
11 secondary outcomes
Histologic Response: Proportion of subjects achieving both MASH resolution (according to NASH CRN classification) without worsening of fibrosis and ≥ 1 stage improvement in liver fibrosis without worsening of MASH
Time frame: Baseline through Week 52
HistoIndex qFibrosis: Proportion of subjects with at least a 1 stage improvement in qFibrosis
Time frame: Baseline through Week 52
Anthropometric parameters: Relative (%) change from baseline in body weight (kg)
Time frame: Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2)
Time frame: Baseline through End of Study (approximately Month 60)
Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm)
Time frame: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in alanine aminotransferase (ALT; U/L)
Time frame: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Time frame: Baseline through End of Study (approximately Month 60)
Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Relative (%) change from baseline in vibration controlled transient elastography (VCTE; kPa) by Fibroscan
Time frame: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.
Time frame: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in Short-form 36 (SF-36) summary scores.
Time frame: Baseline through End of Study (approximately Month 60)
HRQoL: Change from baseline in Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis (CLDQ-NASH) domain scores.
Time frame: Baseline through End of Study (approximately Month 60)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 3
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
RecruitingPhase 3
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
Metabolic Dysfunction-associated Steatohepatitis
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pemvidutide in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Altimmune, Inc. at 9 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaheen Tomah, MD (240-235-0145, performa@altimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome Event (time frame: Baseline through end of study (approximately Month 60)). 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?
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 23 Sep 2026.