Altimmune begins Phase 3 trial of pemvidutide in MASH
A Phase 3 start moves pemvidutide one step closer to a possible filing in liver disease, but no trial timeline has been disclosed and the drug is not approved for any use.
Altimmune said on August 3, 2026 that it has started PERFORMA, a global registrational Phase 3 trial of pemvidutide in MASH, testing fibrosis improvement and MASH resolution [1]. MASH is short for metabolic dysfunction-associated steatohepatitis, a form of liver disease. The new trial follows positive results from the IMPACT Phase 2b study of the same drug [1].
Pemvidutide is a GLP-1/glucagon dual agonist [1]. Its obesity program is still listed at Phase 2, with about 15.6% weight loss reported at 48 weeks, while the MASH program is now described as a registrational Phase 3 [1]. A summary of the company's case notes that the glucagon component of the molecule also acts on the liver, which is the basis for testing it in MASH [1].
The MASH announcement is not the only recent pemvidutide news. On July 28, 2026, a Phase 2 trial of the drug in alcohol use disorder, called RECLAIM, met its primary endpoint, with weight change of -9.1% versus placebo, and registrational secondary endpoints were also met [1].
Altimmune's market value was roughly $440 million to $590 million as of July 2026, and it reported about $535 million in cash as of April 30, 2026, including a $225 million raise completed in April 2026 [1]. Second-quarter results are due August 12 [1]. The same coverage describes the company as small and speculative, in a crowded drug class, with a binary Phase 3 ahead [1].
Several basic details about PERFORMA have not been disclosed. The announcement did not say how many patients Altimmune plans to enroll, how long they will be followed, how many countries or study sites are involved, or when results are expected [1]. The description released so far covers fibrosis improvement and MASH resolution as the things being tested [1]. Results from the trial have not been reported [1].
It also is not yet known whether the Phase 2b results will carry over into Phase 3. Early-stage success in this disease area does not guarantee a registrational trial will hit its endpoints, and for pemvidutide in MASH specifically, only the Phase 2b data has been described as positive so far [1].
Why it matters for patients
Pemvidutide is not approved for any use, so a Phase 3 start does not make it available to patients outside clinical trials [1]. For people with MASH, this announcement does not add an option now, and no date has been given for when the trial might produce results [1].
For people watching pemvidutide for weight loss, the path is longer. The obesity program is still in Phase 2, and the Phase 3 that just began is for liver disease rather than weight management [1].
The access picture for approved GLP-1 medicines is moving separately from any of this. Indiana confirmed it will cover GLP-1 medicines for obesity through the federal BALANCE model, paying about $85 per patient per month against a listed $245, with the rest covered by federal contributions and manufacturer discounts [1]. At the same time, the number of state Medicaid programs covering obesity medicines fell from 16 in 2025 to 13 at the start of 2026 as budget pressure pushed states out [1]. Those changes apply to approved products, not to pemvidutide.
What happens next
August 12, 2026: Altimmune is scheduled to report second-quarter results, which may include more detail on PERFORMA [1].
No timeline has been announced for enrollment completion or for topline data from the pemvidutide MASH Phase 3 trial [1].
Sources
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