On August 3, 2026, Altimmune said it has begun enrolling patients in PERFORMA, a global registrational Phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced fibrosis (F2-F3). The GlobeNewswire announcement and the company IR mirror describe the start as the move from IMPACT Phase 2b into a pivotal MASH program.
Enrollment start is an operational milestone. It is not Phase 3 efficacy, not a 52-week histologic win, and not FDA approval. The numbers that already exist are company 48-week non-invasive tests from IMPACT. IMPACT's primary efficacy endpoints were at 24 weeks. This article does not treat the 48-week NIT table as a substitute for those biopsies, or for PERFORMA.
Pemvidutide is an investigational balanced 1:1 glucagon/GLP-1 dual receptor agonist peptide. Altimmune also has it in development for alcohol use disorder (AUD) and alcohol-associated liver disease (ALD). It is not semaglutide, not tirzepatide, and not a research-vendor "glucagon/GLP-1" vial.
What happened
Altimmune announced on August 3, 2026, that PERFORMA has begun enrolling. ClinicalTrials.gov NCT07795164 lists the study as RECRUITING, with a start date of 2026-07-30. This article treats August 3 as the company announcement date and July 30 as the registry start.
PERFORMA is a global, randomized, double-blind, placebo-controlled, parallel-group Phase 3 trial. The company calls it a registrational study for MASH. It is event-driven, with an interim analysis intended to support accelerated approval. Cohort 1 is designed for biopsy-assessed primary efficacy at 52 weeks (MASH resolution and/or fibrosis improvement). The 52-week readout is anticipated in 2029, per company guidance. Final approval, in the company's framing, would rest on liver-related clinical outcomes at about 60 months.
ClinicalTrials.gov NCT07795164 lists estimated enrollment of about 1,800, estimated primary completion in December 2028, and estimated completion in December 2032. The company cohort figures are about 990 plus about 800, or about 1,790. The 2028 registry primary-completion window and the 2029 company readout are both public dates. They are not the same sentence.
The company says PERFORMA integrates the FDA-qualified AIM-MASH AI Assist tool for histologic assessment. That is a scoring aid named in the August 3 release. It is not a result.
Altimmune also restates FDA Fast Track designations for MASH and AUD, and Breakthrough Therapy Designation for MASH. Those are development designations. They are not approvals.
Why this peptide is not a research vial, and not an approved MASH shot
Pemvidutide is a peptide dual agonist. In the December 19, 2025 IMPACT release and the August 3 Phase 3 announcement, Altimmune describes it as a balanced 1:1 glucagon/GLP-1 dual receptor agonist. Weekly GLP-1 agonists such as semaglutide and dual GLP-1/GIP agonists such as tirzepatide are different molecules with different labels. PeptidePrices has already mapped how GLP-1 drugs moved into MASH and other indications. Sharing a receptor conversation is not sharing a product.
Research-vendor listings that use "glucagon/GLP-1," "ALT," or a pemvidutide-like name are not Altimmune's investigational product. A COA check can tell you whether paperwork names a real lab. It cannot turn an unapproved research vial into the PERFORMA peptide.
The milligram figures below are trial-design and company-topline numbers. They are not a consumer dosing protocol.
What PERFORMA is designed to test
The August 3 release and NCT07795164 describe a two-cohort Phase 3. They do not describe a result.
| Item | Company (August 3, 2026) | ClinicalTrials.gov NCT07795164 |
|---|---|---|
| Status | Began enrolling | RECRUITING |
| Design | Global, randomized, double-blind, placebo-controlled, parallel-group Phase 3 | Same, plus quadruple masking |
| Population | MASH with moderate-to-advanced fibrosis (F2-F3) | Noncirrhotic F2 or F3 MASH |
| Weekly arms | 1.8 mg and 2.4 mg subcutaneously, or placebo, with 1- or 2-step monthly titration from 1.2 mg | 1.8 mg, 2.4 mg, or placebo |
| Cohort 1 | About 990 patients, biopsy-assessed primary efficacy at 52 weeks (MASH resolution and/or fibrosis improvement) | Assigned by screening histologic (liver biopsy) criteria, or a historical biopsy within 6 months |
| Cohort 2 | About 800 patients with fibrosis via non-invasive tests, for the safety dataset | Assigned by non-invasive test criteria |
| Total N | About 1,790 from the two cohort figures | About 1,800 estimated |
| Interim / accelerated path | Event-driven study with interim analysis intended to support accelerated approval | 52-week histologic endpoints: MASH resolution without fibrosis worsening; at least 1-stage fibrosis improvement without MASH worsening |
| Final path | Liver-related clinical outcomes at about 60 months | Time to first histologic progression to cirrhosis (F4), liver-related events, liver transplantation, or death, through about month 60 |
| Dates | 52-week readout anticipated in 2029 | Start 2026-07-30. Primary completion 2028-12. Completion 2032-12 |
| Histology tool | FDA-qualified AIM-MASH AI Assist | Not restated on the registry page fetched for this article |
The registry also lists a 52-week composite secondary: both MASH resolution without fibrosis worsening and at least one-stage fibrosis improvement without MASH worsening. Weight, BMI, waist, ALT, ELF, vibration-controlled transient elastography, and quality-of-life scores run through about month 60. Those are protocol endpoints. They are not data.
The registry primary histologic looks are at week 52. The clinical-outcome primary is time-to-event through about 60 months. An interim analysis intended to support accelerated approval is a company design claim. It is not a completed interim.
NCT07795164 eligibility, as posted, includes adults 18 to 75 years, BMI of at least 25.0 kg/m2 (at least 23.0 kg/m2 if Asian), type 2 diabetes or at least two components of metabolic syndrome, and agreement to protocol biopsies. Cirrhosis (F4), portal hypertension, hepatic decompensation, and other chronic liver disease are exclusions. Those are inclusion rules, not results.
IMPACT Phase 2b: 24-week histology endpoints, 48-week NITs
IMPACT (NCT05989711) is the completed Phase 2b study that Altimmune cites as the basis for PERFORMA. The December 19, 2025 GlobeNewswire topline reported 48-week non-invasive and weight results. The same 48-week package appears in the December 19, 2025 Form 8-K. ClinicalTrials.gov lists actual enrollment of 212 and marks the study completed, with primary completion on November 25, 2025.
The trial randomized adults with biopsy-confirmed MASH F2/F3 1:2:2 to weekly pemvidutide 1.2 mg, 1.8 mg, or placebo for 48 weeks. The primary efficacy endpoints were at 24 weeks: MASH (NASH) resolution without fibrosis worsening, or fibrosis improvement without MASH (NASH) worsening. NCT05989711 matches that 24-week histology pair and also lists treatment-emergent adverse events among the primary outcome measures, with a 52-week safety window.
Those 24-week histologic endpoints are not the 48-week table below. The 48-week highlights are largely NITs, weight, and safety. The company has used language about statistically significant MASH resolution rates at IMPACT. This article attributes that phrasing to the company and does not reprint a 48-week histology table that the assigned sources do not provide. The concrete 48-week numbers are the ones that follow.
The company also said an end-of-Phase 2 FDA meeting aligned on Phase 3 parameters. A completed meeting is not proof that 48-week NITs will become 52-week histology or 60-month outcomes.
IMPACT 48-week company topline
These figures are sponsor topline from the December 19, 2025 release and the furnished 8-K. They are not a peer-reviewed paper in the sources used here.
| Measure at 48 weeks | 1.2 mg | 1.8 mg | Placebo |
|---|---|---|---|
| ELF change | -0.49 (p<0.0001) | -0.58 (p<0.0001) | +0.16 |
| LSM change | -3.04 (p<0.05) | -3.97 (p<0.001) | -0.03 |
| Both at least 0.5 ELF reduction AND 30% LSM reduction | 27.8% (p<0.001) | 32.4% (p<0.0001) | 3.2% |
| Liver fat | -45.2% (p<0.0001) | -54.7% (p<0.0001) | -8.2% |
| ALT | -37.8 IU/L (p<0.0001) | -37.4 IU/L (p<0.0001) | -10.3 IU/L |
| cT1 | -124 ms (p<0.0001) | -140 ms (p<0.0001) | -21 ms |
| Weight loss | 4.5% (p<0.0001) | 7.5% (p<0.0001) | 0.2% |
| AE discontinuations | 0% | 1.2% | 3.5% |
The company said there was no plateau in weight loss at 1.8 mg at 48 weeks. That is a company reading of a Phase 2b curve. It is not evidence that loss continues through 52-week or 60-month Phase 3.
The company reported no serious or severe treatment-related adverse events. That is a sponsor safety summary in a 212-person Phase 2b, not a Phase 3 label.
IMPACT doses are not PERFORMA doses. IMPACT tested 1.2 mg and 1.8 mg. PERFORMA is testing 1.8 mg and 2.4 mg, with titration from 1.2 mg. The 7.5% weight figure is the 1.8 mg, 48-week IMPACT result. It is not a 2.4 mg, 52-week PERFORMA result.
ELF, LSM, liver fat, ALT, and cT1 can move with histology and with liver-related events in the broader MASH literature. The company makes that association in the December 19 release. Association in prior datasets is not the same as PERFORMA proving MASH resolution or fibrosis improvement on biopsy.
What this does not mean
- It is not FDA approval. Pemvidutide is not approved for MASH, obesity, AUD, ALD, or any other use.
- Phase 3 start is not Phase 3 efficacy. PERFORMA has begun enrolling. It has not shown 52-week histology or 60-month outcomes.
- IMPACT Phase 2b NITs are not Phase 3 histologic or clinical outcomes. ELF, LSM, liver fat, ALT, and cT1 at 48 weeks are not the PERFORMA biopsy or event endpoints.
- Breakthrough Therapy and Fast Track are FDA development designations. They are not approvals.
- Pemvidutide is not available as a compounded or research-vendor product for human use as an approved drug. Catalog "glucagon/GLP-1" vials were not the intervention in IMPACT or PERFORMA.
- This is not medical advice, and it is not a consumer dosing protocol. The milligram figures above are trial-design and company-topline numbers.
What to watch next
- Whether week 52 remains the histologic look for accelerated approval. That is the company and registry design today.
- The 2028-2029 readout window. ClinicalTrials.gov lists primary completion in December 2028. The company anticipates the 52-week readout in 2029.
- Enrollment versus the 1,800 / 1,790 figures. The registry estimate is about 1,800. The two company cohorts add to about 1,790.
- A peer-reviewed IMPACT paper. The 48-week NIT table is still company topline in the sources used here.
- The 60-month outcomes path. Time to cirrhosis, liver events, transplant, or death is the long readout. An interim is not that readout.
- Whether AIM-MASH AI Assist is described in later protocols the same way. The August 3 release says the tool is integrated. The registry page fetched here does not restate it.
For the wider incretin and MASH map, see GLP-1s beyond weight loss and the ADA 2026 GLP-1 pipeline roundup. Live semaglutide and tirzepatide listing pages are price-and-vendor views of different products.
FAQs
Did Altimmune start Phase 3 for pemvidutide in MASH?
The company said on August 3, 2026, that PERFORMA has begun enrolling. ClinicalTrials.gov NCT07795164 lists the study as RECRUITING, with a start date of 2026-07-30. That is not a results announcement.
What did IMPACT Phase 2b show at 48 weeks?
Company topline, not a peer-reviewed paper in the sources used here: ELF -0.49 and -0.58 versus +0.16 placebo; LSM -3.04 and -3.97 versus -0.03; liver fat -45.2% and -54.7% versus -8.2%; weight loss 4.5% and 7.5% versus 0.2%. Primary efficacy endpoints were at 24 weeks.
Is pemvidutide FDA-approved?
No. Fast Track (MASH and AUD) and Breakthrough Therapy Designation (MASH) are development designations. They are not approvals.
Is this the same as semaglutide, tirzepatide, or a research-vendor glucagon/GLP-1?
No. Pemvidutide is an investigational 1:1 glucagon/GLP-1 peptide. Semaglutide and tirzepatide are different approved products. Research-vendor listings were not the IMPACT or PERFORMA intervention.
When are PERFORMA results expected?
The company anticipates the 52-week readout in 2029. ClinicalTrials.gov lists primary completion in December 2028 and completion in December 2032. Final approval, in the company's framing, depends on liver-related outcomes at about 60 months.
Can someone buy pemvidutide from a research vendor?
No legitimate retail or research-vendor path makes a catalog vial Altimmune's investigational peptide. IMPACT and PERFORMA used a controlled trial product, not a research-chemical listing.
This article is for general informational purposes only and is not medical advice. Talk to a licensed clinician about personal medical decisions. Pemvidutide is an investigational peptide studied in controlled trials. Nothing here is a dosing protocol, an availability claim, or a recommendation to obtain an unapproved product.
Continue your research
- Semaglutide price comparison
- Tirzepatide price comparison
- GLP-1s Are Becoming "Everything" Drugs
- What the GLP-1 Pipeline Showed at ADA 2026
- COA Authenticity Checker
Sources
- Altimmune. Altimmune initiates PERFORMA Phase 3 trial of pemvidutide in patients with MASH. GlobeNewswire. August 3, 2026
- Altimmune. PERFORMA Phase 3 initiation, IR mirror. August 3, 2026
- ClinicalTrials.gov NCT07795164. PERFORMA: Phase 3 pemvidutide in MASH
- Altimmune. Pemvidutide achieved key measures of success at 48 weeks in IMPACT Phase 2b MASH trial. GlobeNewswire. December 19, 2025
- ClinicalTrials.gov NCT05989711. IMPACT: Phase 2 pemvidutide in NASH/MASH
- Altimmune, Inc. Current Report on Form 8-K. Filed December 19, 2025