Drug evidence profileInvestigational - not FDA approved

Pemvidutide: trials, results, and current status.

Also searched as ALT-801 · balanced GLP-1/glucagon dual agonist · Altimmune pemvidutide

Pemvidutide, formerly ALT-801, is Altimmune's investigational once-weekly peptide with balanced GLP-1 and glucagon receptor activity. It has a completed Phase 2 obesity record, a completed Phase 2b MASH study, and active studies in alcohol-related conditions. Altimmune plans a multinational MASH Phase 3 trial, but pemvidutide is not FDA approved and has no authenticated retail product or commercial dosing route.

Approval and access

Is pemvidutide in Phase 3 or available now?

Altimmune plans to begin the multinational PERFORMA Phase 3 MASH trial in the second half of 2026. Current records also include completed IMPACT Phase 2b MASH work, an active Phase 2 alcohol-use-disorder study, and a recruiting alcohol-associated-liver-disease study. The FDA designations for MASH and alcohol use disorder are development tools, not approvals. Pemvidutide is not FDA approved and has no legitimate approved retail product, label, commercial price, pharmacy channel, or routine prescribing pathway.

Live decision workspace

Compare Pemvidutide with Retatrutide, without losing the country context.

Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.

AIdentity record
Pemvidutide

Investigational clinical program

No linked research price board
Destination fixedUnited StatesNorth America

Official product and seller records attached

BComparison record
Retatrutide

Investigational clinical program

No linked research price board
01 · Status02 · Trials03 · Country04 · Price
Current program snapshot

What can you conclude about Pemvidutide today?

These are dated program facts, not a cross-trial ranking, approval forecast, personal treatment recommendation, or proof that a same-name online product is the sponsor's medicine.

MOMENTUM obesity15.6% at 48 weeks

Mean change with 2.4 mg versus 2.2% with placebo in 391 adults without diabetes, according to the sponsor report.

IMPACT MASH7.5% at 48 weeks

Weight change with 1.8 mg in the MASH population, alongside liver and cardiometabolic endpoints.

FDA designationsBreakthrough + Fast Track

Breakthrough Therapy for MASH and Fast Track designations for MASH and alcohol use disorder are not approvals.

Next pivotal stepPERFORMA planned

Altimmune says a multinational MASH Phase 3 trial is planned for the second half of 2026.

Marketing and authorization statusInvestigational - not FDA approved
Evidence checked July 18, 2026Open lead source
Program identity

Know which molecule the result belongs to.

Sponsor
Altimmune
Mechanism
Balanced 1:1 GLP-1 and glucagon receptor dual agonist
Route being studied
Once-weekly subcutaneous injection
Current stage
Phase 2 programs active; MASH Phase 3 planned
Featured trial anchors
NCT05989711 · NCT06987513 · NCT07009860 · NCT05006885
Evidence checked
July 18, 2026
Sourced weight-loss trial results

Pemvidutide weight-loss results, with the trial attached.

This visual shows one selected result, not every dose or endpoint in the program. The percentage remains attached to its duration, population, comparator, analysis method, and source.

Evidence checked July 21, 2026
Phase 2Weekly injection
NCT05295875
15.6%Active-arm mean
MOMENTUM48 weeks

Pemvidutide reported 15.6% mean reduction at 48 weeks under the sponsor-reported 48-week mean. The comparator recorded 2.2% mean reduction.

Pemvidutide reported mean15.6%
Comparator mean2.2% mean reduction

Bar lengths share a 0 to 30% visual scale. They describe this selected record and do not make separate trials head-to-head.

Population
Adults with obesity, or overweight plus a comorbidity
Participants
391 Total randomized trial population
Dose
2.4 mg
Primary analysis
Sponsor-reported 48-week mean
Regulatory status
Investigational; not FDA approved
ClinicalTrials.gov program landscape

Pemvidutide clinical trials by status, phase, and location.

The current exact-intervention snapshot matches 9 unique NCT records. This chart describes registry coverage and current study fields. It does not compare efficacy, safety, approval probability, eligibility, or treatment access.

Snapshot 2026-07-24
9matched NCT records
1overall Recruiting
0registry results posted
8recruiting site observations
1countries with recruiting sites
Registry phase mix2 phase labels
Phase labels come from ClinicalTrials.gov. A larger phase count is not stronger evidence or a better program.
Registry geographyTop current recruiting-site observations

Counts use individual locations currently marked Recruiting, not every facility listed on an overall-recruiting study. Repeated centers across studies remain repeated site observations.

Countries3 represented
01United States1 recruiting study8 sites02Australia0 recruiting studies0 sites03Puerto Rico0 recruiting studies0 sites
United States28 states represented
01Florida1 recruiting study2 sites02Texas1 recruiting study2 sites03New York1 recruiting study2 sites04Missouri1 recruiting study1 sites05Arkansas1 recruiting study1 sites06California0 recruiting studies0 sites
Worldwide status map

Pemvidutide across 42 countries.

This profile establishes the program identity and its cited clinical or regulatory record. It does not turn a same-name seller listing into the sponsor’s asset or prove authorization, availability, or lawful supply in another destination.

Compare Pemvidutide by country →Compare Pemvidutide by US state →Browse the global peptide country dataset →
Country-specific status checks

Is Pemvidutide approved or available in your country?

Start with the United States FDA record, then check the destination that matters to you. Each country page separates drug identity, authorization, product records, seller claims, and supply rules. Directory checked July 20, 2026.

Evidence ledger

What the record shows - and what it doesn’t.

Trial percentages are kept beside the design details that make them interpretable. Unknowns stay visible instead of being filled with launch speculation.

Supported
01

MOMENTUM established a substantial obesity signal

The 48-week Phase 2 MOMENTUM trial enrolled 391 adults with obesity, or overweight plus a comorbidity, without diabetes. Altimmune reported mean changes of 10.3%, 11.2%, and 15.6% for weekly 1.2 mg, 1.8 mg, and 2.4 mg pemvidutide versus 2.2% with placebo. The result supports the development history but is not a Phase 3 obesity outcome, an approved indication, or a head-to-head comparison with another drug.

02

IMPACT addresses a different MASH question

IMPACT randomized 212 people with biopsy-confirmed MASH and F2 or F3 fibrosis to weekly pemvidutide or placebo for 48 weeks. The peer-reviewed 24-week report and sponsor's 48-week update cover liver histology, non-invasive fibrosis measures, cardiometabolic outcomes, and weight. At 48 weeks, Altimmune reported 7.5% weight loss with 1.8 mg and about 1% discontinuation because of adverse events across pemvidutide participants.

03

Regulatory designations and Phase 3 plans are not approval

The FDA granted Breakthrough Therapy designation for pemvidutide in MASH and Fast Track designations for MASH and alcohol use disorder. Altimmune says PERFORMA is planned as a multinational randomized Phase 3 MASH study in the second half of 2026. A designation can support development and review interactions, but it does not establish efficacy, an approved label, a decision date, market supply, or a commercial product.

Not established
01

No registered PERFORMA outcome exists

The current sponsor plan describes a future MASH Phase 3 trial. Until a registry record and later results are available, enrollment, doses, countries, endpoints, duration, discontinuations, and outcomes remain unconfirmed or incomplete. A planned pivotal study is not evidence that the program will be approved.

02

No FDA-approved pemvidutide product

Pemvidutide has no FDA-approved indication, prescribing information, application number, final dose, pharmacy presentation, retail price, insurance coverage, or routine clinical supply channel. An online listing using pemvidutide or ALT-801 does not become Altimmune clinical material by sharing a name.

03

Obesity and MASH percentages cannot be merged

MOMENTUM and IMPACT studied different populations, doses, endpoints, and clinical questions. Their 48-week weight percentages should not be averaged, substituted, or used to rank pemvidutide against survodutide, mazdutide, retatrutide, semaglutide, or another program without a common randomized protocol.

Direct answers

The questions behind the search.

Concise answers based on the dated sponsor and trial records below. This is educational reporting, not medical advice.

01

What is pemvidutide, and is it the same as ALT-801?

Yes. Pemvidutide is the current name for the Altimmune peptide previously identified as ALT-801. It is designed as a balanced 1:1 agonist of the GLP-1 and glucagon receptors and is administered once weekly by subcutaneous injection in trials. The GLP-1 component is intended to affect appetite and metabolic signalling, while glucagon activity is being studied for direct liver and energy-expenditure effects. Those mechanism claims describe an investigational program, not an approved indication, consumer dose, retail product, or authenticated online vial.

02

How much weight loss did pemvidutide produce?

In the sponsor-reported 48-week MOMENTUM obesity trial, mean weight loss was 15.6% with the 2.4 mg weekly group versus 2.2% with placebo. In the separate IMPACT MASH study, Altimmune reported 7.5% weight loss with 1.8 mg at week 48. These figures come from different populations and development questions. Neither predicts an individual's result, establishes an approved dose, or creates a fair direct ranking against retatrutide, survodutide, mazdutide, semaglutide, tirzepatide, or another drug.

03

Is pemvidutide in Phase 3 or available now?

Altimmune plans to begin the multinational PERFORMA Phase 3 MASH trial in the second half of 2026. Current records also include completed IMPACT Phase 2b MASH work, an active Phase 2 alcohol-use-disorder study, and a recruiting alcohol-associated-liver-disease study. The FDA designations for MASH and alcohol use disorder are development tools, not approvals. Pemvidutide is not FDA approved and has no legitimate approved retail product, label, commercial price, pharmacy channel, or routine prescribing pathway.

Important boundaryApproval status is jurisdiction-specific.

Do not use an investigational name, trial dose, or online research listing as a substitute for approved care. This page does not recommend treatment, sourcing, or participation in a clinical trial.

Understand the product-category boundary →
Primary referencesIMPACT Phase 2b MASH study - NCT05989711Completed status, 212-participant design, MASH population, weekly doses, endpoints, study dates, and publication linkClinicalTrials.gov · Record checked July 18, 2026IMPACT 24-week peer-reviewed publicationRandomized Phase 2b design, MASH histology outcomes, safety context, and trial interpretationPubMed / The Lancet · November 11, 2025IMPACT 48-week results and PERFORMA planWeek-48 weight and cardiometabolic results, adverse-event discontinuation, FDA designations, and planned MASH Phase 3 timingAltimmune · May 28, 2026MOMENTUM 48-week obesity results391-participant design, dose groups, week-48 weight results, body-composition analysis, mechanism, and safety summaryAltimmune · June 23, 2024Pemvidutide development profileSponsor identity, peptide mechanism, current indications, FDA designations, IMPACT status, and active development programsAltimmune · Record checked July 18, 2026FDA Breakthrough Therapy designation for MASHDesignation, intended MASH development path, regulatory boundary, and investigational statusAltimmune · January 5, 2026RECLAIM Phase 2 study - NCT06987513Alcohol use disorder study design, population, weekly route, enrollment, endpoints, and active-not-recruiting statusClinicalTrials.gov · Record checked July 18, 2026RESTORE Phase 2 study - NCT07009860Alcohol-associated liver disease study design, population, weekly route, endpoints, and recruiting statusClinicalTrials.gov · Record checked July 18, 2026Pemvidutide MASLD randomized studyPeer-reviewed liver-fat, inflammation, weight, mechanism, and safety evidence from the earlier MASLD programPubMed / Journal of Hepatology · July 16, 2024