Pemvidutide

Supplied Navaro guide

Research Sources

Use clean canonical URLs in production .

1. ClinicalT rials.gov: MOMENTUM Evidence type: Registered Phase 2 obesity study Supports:

• obesity population

• randomized clinical design

• SC pemvidutide research

• weekly administration framework

https://clinicaltrials.gov/study/NCT05295875 2. Altimmune: MOMENTUM Results Evidence type: Sponsor-reported Phase 2 results Supports:

• 1.2 mg

• 1.8 mg

• 2.4 mg

• 48-week weight-loss outcomes

Canonical Altimmune investor release should be used in production.

3. Harrison et al.: Pemvidutide in MASLD Evidence type: Peer-reviewed randomized human research Supports:

• weekly administration

• liver-fat reduction

• body-weight reduction

• metabolic/liver effects

https://pubmed.ncbi.nlm.nih.gov/39002641/ 4. Browne et al.: 24-W eek MASLD Research Evidence type: Human randomized clinical research Supports:

• 24-week treatment

• 1.2 mg

• 1.8 mg

• 2.4 mg

• 56.3%, 75.2% and 76.4% liver-fat reductions

https://pubmed.ncbi.nlm.nih.gov/41113119/ 5. IMP ACT Phase 2b Evidence type: Randomized human MASH research Supports:

• 1.2 mg / 1.8 mg

• MASH outcomes

• fibrosis-related outcomes

https://clinicaltrials.gov/study/NCT05989711 6. Altimmune: Breakthrough Therapy Designation Evidence type: Sponsor regulatory-development announcement Supports:

• FDA Breakthrough Therapy Designation for MASH

• Fast Track status

• Phase 3 alignment

https://ir.altimmune.com/news-releases/news-release-details/altimmune-receives-fda-breakthrough-therapy-designation 7. ClinicalT rials.gov: RECLAIM Evidence type: Registered Phase 2 AUD trial Supports:

• 2.4 mg weekly

• approximately 100 participants

• 24-week design

https://clinicaltrials.gov/study/NCT06987513 8. Altimmune: RECLAIM T opline Results Evidence type: Sponsor-reported Phase 2 topline results Supports:

• July 2026 positive AUD results

• primary heavy-drinking-day endpoint

Use the canonical Altimmune release in production.

9. Altimmune: PERFORMA Phase 3 Evidence type: Current sponsor development source Supports:

• Phase 3 initiation

• August 3, 2026 start

• MASH registrational program

Use the canonical Altimmune PERFORMA press release in production.

Final Takeaway

Pemvidutide is a late-stage investigational drug with substantial human evidence. It should not be treated like a lightly studied research peptide, but it also should not be written about as if it were already FDA approved.

The strongest current protocol evidence supports:

once-weekly SC administration with major human trial doses including:

1.2 mg 1.8 mg and:

2.4 mg.

Those are:

clinical-trial doses not an approved:

1.2 → 1.8 → 2.4 mg dosing ladder.

For weight loss, Phase 2 research reported up to approximately:

15.6% mean weight loss at 48 weeks .

For liver disease, pemvidutide has produced:

• large liver-fat reductions

• significant MASH-resolution activity

and has now progressed into:

Phase 3 MASH development.

For alcohol use disorder:

positive Phase 2 topline results were announced in July 2026 , but this remains an investigational indication.

The biggest production rules to preserve are:

Do not call 1.2 mg the universal starting dose, 1.8 mg the standard maintenance dose, or 2.4 mg the advanced dose.

They are trial doses, not an FDA-approved ladder.

Keep once-weekly SC dosing because that is directly supported by the human program.

Do not copy formal contraindications from approved GLP-1 drugs onto pemvidutide.

Add PERFORMA Phase 3 prominently .

Add RECLAIM AUD results, but identify them as sponsorreported Phase 2 topline data.

Do not use generic 14–28-day research-vial storage rules as though they came from the clinical program.

This is the Pemvidutide page I would carry forward as the production version.

Navaro Compounds.pdf, pages 211–251.

Dosing evidence

Dose at a Glance

FDA-Approved Dosing

There is none Pemvidutide is not FDA approved.

There is no FDA-approved:

• starting dose

• maintenance dose

• titration schedule

• commercial injection pen

• commercial vial

• prescribing label

Altimmune continues to describe pemvidutide as investigational.

Human Clinical Research Dosing

MOMENTUM Obesity Trial

Major studied doses included:

1.2 mg once weekly 1.8 mg once weekly 2.4 mg once weekly .

Important These were trial arms .

They should not automatically be converted into:

1.2 mg starting dose → 1.8 mg maintenance → 2.4 mg advanced dose as though that were an approved dosing system.

IMPACT MASH Trial

The Phase 2b IMPACT study used:

1.2 mg once weekly and:

1.8 mg once weekly against placebo.

RECLAIM AUD Trial

RECLAIM used:

2.4 mg once weekly for:

24 weeks .

Important The dose was studied specifically in that Phase 2 AUD protocol.

It does not establish 2.4 mg as a universal public pemvidutide dose.

Research-Community Dosing

Community pages often reuse genuine trial doses such as:

• 1.2 mg

• 1.8 mg

• 2.4 mg

and turn them into a generic dose ladder.

The problem The numbers themselves are real human research doses.

The labels:

• “starting”

• “standard”

• “advanced”

are usually community reinterpretations, not approved clinical categories.

Correct evidence classification 1.2 mg: Human trial dose 1.8 mg: Human trial dose 2.4 mg: Human trial dose 1.2 → 1.8 → 2.4 mg universal ladder: Not established

Frequency at a Glance

Timing at a Glance

There is no human evidence showing pemvidutide needs to be taken:

• in the morning

• at night

• fasted

• with food

• before exercise

• after exercise

The important studied variable is:

weekly administration not a particular clock time.

Evidence verdict Morning required: No Night required: No F asted required: No With food required: No Pre-workout required: No Post-workout required: No

Duration / Cycle at a Glance

Protocol Logic Check

Does Once-Weekly Dosing Make Sense?

Yes.

This is one of the most secure conclusions for pemvidutide.

Major clinical programs use:

once-weekly SC administration.

V erdict Strongly evidence-supported

Does Twice-Weekly Dosing Make Sense?

There is no controlled evidence showing that splitting the weekly dose improves:

• weight loss

• MASH outcomes

• liver-fat reduction

• tolerability

V erdict Not established

Does Daily Dosing Make Sense?

No major clinical pemvidutide program uses daily administration.

V erdict Not established

Morning or Evening?

There is no demonstrated superiority for either.

V erdict Preference, not evidence-based requirement

Does It Need to Be Taken Fasted?

No evidence shows fasting is required.

V erdict Not established

Pre-Workout Timing

Pemvidutide is a long-acting weekly metabolic drug.

There is no evidence that taking it near a workout improves efficacy.

V erdict No demonstrated advantage

Dose Escalation / Titration

This needs careful wording.

The human program has used more than one dosing and titration design.

That means:

titration may be useful for tolerability but:

there is no finalized universal pemvidutide titration system.

V erdict Study-specific

Is 1.2 mg the Starting Dose?

Not in the same sense that an approved GLP-1 product has a labeled starting dose.

1.2 mg is a:

human clinical trial dose not an FDA-established universal starting dose.

Is 1.8 mg the Standard Dose?

No.

It is a well-studied clinical dose, especially in liver research.

But pemvidutide does not have an FDA-approved:

maintenance dose.

Is 2.4 mg the “Advanced Dose”?

No official category exists.

2.4 mg is a genuine human trial dose used in obesity and AUD research.

Calling it:

advanced dose is community language.

V erdict Human trial dose, not official dose tier

Does It Need an 8–12 Week Cycle?

No.

Clinical studies last:

• 24 weeks

• 48 weeks

• and now longer registrational development

rather than short peptide cycles.

V erdict No evidence-based short-cycle requirement

Does It Need a Receptor Reset?

No scheduled GLP-1 or glucagon-receptor reset has been demonstrated.

V erdict No established requirement

Does It Need a Washout?

There is no established:

• 2-week reset

• 4-week reset

• monthly receptor recovery break

as part of chronic pemvidutide treatment.

V erdict No demonstrated requirement

Frequency

Once weekly V erdict Strong match to the human evidence

2. Human Clinical-Trial Doses

These include:

• 1.2 mg

• 1.8 mg

• 2.4 mg

These are genuine human research doses.

But they are:

trial doses not:

FDA-approved public dosing instructions.

Common Research Dose

MOMENTUM Obesity

1.2 mg once weekly 1.8 mg once weekly 2.4 mg once weekly .

IMPACT MASH

1.2 mg once weekly 1.8 mg once weekly .

RECLAIM AUD

2.4 mg once weekly .

Research Duration / Cycle Length

Human Trials

Important treatment periods include:

24 weeks and:

48 weeks with longer-term Phase 3 development now underway.

Evidence assessment Pemvidutide is being developed as:

long-term disease therapy not a short peptide cycle.

How Often It Is Used / Frequency

Community Research Protocol

Community pages may describe:

“Starting” 1.2 mg weekly “Standard” 1.8 mg weekly “Advanced” 2.4 mg weekly Evidence check 1.2 mg: Real human trial dose 1.8 mg: Real human trial dose 2.4 mg: Real human trial dose Starting / standard / advanced labels: Community reinterpretation Correct production wording Use:

Human T rial Dose Examples rather than:

Standard Pemvidutide Protocol

Community Protocol Comparison

Source Dose Route Frequency Evidence MOMENTUM 1.2 mg SC Weekly Phase 2 human MOMENTUM 1.8 mg SC Weekly Phase 2 human MOMENTUM 2.4 mg SC Weekly Phase 2 human IMP ACT 1.2 / 1.8 mg SC Weekly Phase 2b human RECLAIM 2.4 mg SC Weekly Phase 2 human Community ladder 1.2 → 1.8 → 2.4 mg SC Weekly Trial arms repackaged as a protocol Strongest agreement Once-weekly SC administration Biggest mistake to avoid Turning:

separate clinical-trial doses into:

one universal escalation ladder

Expected Results Timeline, Expanded

Evidence

Pemvidutide

GLP-1 / Glucagon Dual Receptor Agonist • MASH Research • W eight-Loss Research

At a Glance

What is Pemvidutide?

Pemvidutide is an investigational peptide drug that activates two hormone receptors:

• the GLP-1 receptor

• the glucagon receptor

Altimmune describes it as a roughly balanced 1:1 GLP-1 / glucagon dual receptor agonist . It is currently being developed primarily for MASH, alcohol use disorder and alcohol-associated liver disease.

GLP-1 activity GLP-1 signaling can help:

• reduce appetite

• increase fullness

• lower food intake

• regulate blood sugar

Glucagon activity Glucagon-receptor signaling has important effects involving:

• liver metabolism

• fat oxidation

• liver fat

• lipid handling

• energy use

Simple version Pemvidutide is designed to combine:

less food intake with:

direct metabolic effects involving the liver.

How well studied is it?

W ell studied for an investigational drug, but it is still not approved Pemvidutide now has:

• Phase 1 human research

• a completed Phase 2 obesity program

• human MASLD studies

• a completed Phase 2b MASH trial

• a completed Phase 2 alcohol-use-disorder trial with topline results

• an ongoing Phase 2 alcohol-associated liver disease program

• an active Phase 3 MASH program

Altimmune initiated the global PERFORMA Phase 3 MASH trial on August 3, 2026 .

Evidence level FDA-approved human evidence: None Human clinical research: Strong for an investigational drug MASH evidence: Strong Phase 2b evidence; Phase 3 underway W eight-loss evidence: Strong Phase 2 evidence Liver-fat evidence: Strong human evidence Alcohol-use-disorder evidence: Positive Phase 2 topline evidence Long-term approved-product safety: Not established Community protocols: Secondary to the clinical-trial evidence

What may it help with?

Weight Loss

The Phase 2 MOMENTUM obesity program studied pemvidutide by onceweekly subcutaneous injection at doses including:

• 1.2 mg

• 1.8 mg

• 2.4 mg.

At 48 weeks, sponsor-reported mean weight loss was approximately:

1.2 mg: 10.3% 1.8 mg: 11.2% 2.4 mg: 15.6% Placebo: 2.2%.

More than 30% of participants receiving 2.4 mg lost at least 20% of baseline body weight in the reported MOMENTUM results.

Important This is meaningful human evidence.

But pemvidutide is still:

investigational and is not an FDA-approved obesity treatment. Altimmune continues to describe it as an investigational product candidate.

MASH

Pemvidutide has substantial human MASH evidence.

The IMPACT Phase 2b trial was designed to assess:

• MASH resolution

• fibrosis outcomes

with pemvidutide versus placebo.

Altimmune reported that the 24-week data demonstrated statistically significant MASH resolution without worsening of fibrosis . The company later reported continued improvements in noninvasive fibrosis-related measures through 48 weeks.

Important Do not simplify this to:

Pemvidutide has proven it reverses fibrosis.

That overstates the evidence.

Better wording Pemvidutide has shown significant MASH activity and encouraging fibrosis-related signals in Phase 2b research.

Phase 3 is now underway to determine whether those findings translate into a registrational treatment benefit.

Liver Fat Reduction

Human MASLD research has shown large reductions in liver fat.

At 24 weeks, relative liver-fat reductions were approximately:

1.2 mg: 56.3% 1.8 mg: 75.2% 2.4 mg: 76.4% Placebo: 14.0%.

That is one of the strongest and most consistent findings in the pemvidutide program.

Alcohol Use Disorder

This is a major 2026 update.

RECLAIM was a Phase 2 trial of approximately 100 adults with alcohol use disorder receiving:

2.4 mg pemvidutide once weekly or placebo for:

24 weeks .

Altimmune announced positive topline results on July 28, 2026 , reporting a statistically significant reduction in heavy-drinking days, along with improvements in important secondary drinking outcomes.

Important These are currently:

sponsor-reported Phase 2 topline results rather than a fully peer-reviewed efficacy paper.

Evidence classification Promising human interventional evidence Not:

approved AUD treatment

What has it NOT been proven to help with?

Pemvidutide has not been established as an approved treatment for:

• obesity

• ordinary weight loss

• type 2 diabetes

• bodybuilding

• muscle growth

• athletic performance

• spot fat loss

• GLP-1-related fatigue

• alcohol-use disorder

• alcohol-associated liver disease

• general “liver detox”

• longevity

• anti-aging

Clinical research may support some of these disease areas in the future.

But:

clinical development is not the same as regulatory approval.

Human Clinical Research

Once weekly This is the clearest dosing feature across the pemvidutide program.

The obesity, liver and AUD programs use once-weekly SC administration.

T wice weekly?

Not established Every 3–4 days?

Not established

Daily?

Not established 5 days on / 2 days off?

Not established Best-supported frequency Once weekly

Human Clinical Research

Pemvidutide has been studied over periods including:

24 weeks

and:

48 weeks and the Phase 3 MASH program is designed as longer-term disease treatment.

Does pemvidutide need cycling?

No receptor-reset cycle has been established.

There is no evidence-based requirement for:

• 8 weeks on / 4 weeks off

• 12-week cycles

• 5 days on / 2 days off

• monthly washouts

• GLP-1 receptor resets

• glucagon receptor resets

Expected Results Timeline

Weight-Loss Research

Early weeks Appetite and gastrointestinal effects may occur relatively early.

But clinically meaningful weight loss is evaluated over:

months rather than days.

Around 24 Weeks

Meaningful body-weight changes are already measurable in liver/metabolic trials by this point.

Human MASLD research also showed major liver-fat reductions by 24 weeks .

Around 48 Weeks

MOMENTUM reported mean weight losses of approximately:

1.2 mg: 10.3% 1.8 mg: 11.2%

2.4 mg: 15.6% at 48 weeks.

Clinical takeaway Think in months, not days.

Liver Results Timeline

Around 12–24 Weeks

Substantial liver-fat changes have been observed during this period.

At 24 weeks, relative liver-fat reductions reached approximately 75–76% in the 1.8 and 2.4 mg groups in the MASLD extension study.

MASH Histology

The IMPACT Phase 2b program formally evaluated biopsy-based MASH outcomes and generated positive 24-week results, followed by additional 48-week data.

Community-Reported Timeline

Community material often describes:

• early appetite suppression

• early GI effects

• progressive weight loss over weeks and months

But many of the percentages quoted online are simply copied from clinical trials.

Important Separate:

actual trial timelines from:

community anecdotes rather than combining the two.

Best top-card wording Clinical: measurable weight and liver changes develop over months, with important trial endpoints assessed around 24 and 48 weeks.

Community-reported: appetite and GI changes are often described earlier, but community timelines should not be mistaken for controlled trial outcomes.

Regulatory Status at a Glance

FDA Approved?

No Pemvidutide remains investigational.

Fast Track

Pemvidutide has received FDA Fast Track designation for:

MASH and:

alcohol use disorder .

Breakthrough Therapy Designation

MASH Y es

FDA granted Breakthrough Therapy Designation for MASH on January 5, 2026.

Important Breakthrough Therapy Designation does not mean FDA approval.

It is intended to expedite development and review when preliminary clinical evidence suggests substantial potential benefit.

Phase 3

Y es Altimmune initiated the global PERFORMA Phase 3 MASH trial on August 3, 2026 .

Production wording Pemvidutide is now a Phase 3 investigational drug for MASH, but it remains unapproved.

Bottom Line

Pemvidutide has much stronger human evidence than most compounds sold as “research peptides,” but it remains an investigational drug.

The strongest dosing evidence supports:

once-weekly subcutaneous administration.

Major human trial doses include:

1.2 mg 1.8 mg and:

2.4 mg but those should not automatically be turned into a universal:

starting → standard → advanced dose system.

Pemvidutide has meaningful human evidence for:

• weight loss

• liver-fat reduction

• MASH improvement

and now sponsor-reported Phase 2 evidence for:

• alcohol use disorder.

It has also now entered:

Phase 3 MASH development.

Quick Logic Summary

Protocol Question Verdict GLP-1 receptor agonism? Evidence-supported Glucagon receptor agonism? Evidence-supported Balanced dual agonist? Y es Once-weekly SC dosing? Strongly supported 1.2 mg studied in humans? Y es 1.8 mg studied in humans? Y es 2.4 mg studied in humans? Y es 1.2 → 1.8 → 2.4 mg universal titration? No 1.8 mg universal maintenance dose? No 2.4 mg universal “advanced dose”? No Morning dosing better? Not shown Fasted dosing required? No Pre-workout dosing useful? No demonstrated reason Twice-weekly dosing? Not established 8–12 week cycle? No demonstrated rationale Receptor reset? No established requirement Stack with semaglutide? Major pathway overlap Generic research-vial stability? Cannot be assumed FDA approved? No Phase 3 underway? Y es

What Does Pemvidutide Target?

Pemvidutide activates:

GLP-1 receptors and:

glucagon receptors .

Simple version The two pathways contribute different effects.

GLP-1 Primarily helps:

reduce appetite and food intake Glucagon Has important effects involving:

the liver and energy metabolism Together, the drug is intended to affect both:

energy intake and:

how stored fuel is handled metabolically .

V erdict W ell established mechanism

Does Glucagon Just Raise Blood Sugar?

No.

Glucagon can raise blood glucose, but glucagon-receptor signaling also affects:

• liver metabolism

• fatty-acid oxidation

• lipid handling

• energy expenditure

Altimmune’s development rationale specifically emphasizes direct liver effects from glucagon-receptor activation alongside appetite and weight effects mediated through GLP-1.

Human Half-Life

Pemvidutide is pharmacologically long acting enough for:

once-weekly administration which is directly supported by the human clinical-development program.

Important The page does not need to convert a quoted half-life into an amateur dosing formula.

Better rule Use the human clinical schedule rather than reverseengineering frequency from half-life alone.

Does the Route Match the Research?

Major Human Trials

Subcutaneous

Important Research Note

Three different pemvidutide contexts are often mixed together.

1. Clinical-Trial Pemvidutide

This is Altimmune’s controlled investigational drug.

Clinical trials have:

• controlled manufacturing

• defined formulation

• defined route

• defined dose

• clinical monitoring

3. Community Research Pemvidutide

Online research products may differ in:

• manufacturing

• formulation

• excipients

• sterility

• purity

• concentration

• handling

A vial labeled:

Pemvidutide 10 mg

cannot automatically be assumed to match the investigational product used in Altimmune trials.

Research at a Glance

Approved-Label Human Evidence

None Pemvidutide is not FDA approved.

Human Clinical Research

Strong for an investigational drug There is meaningful Phase 1, Phase 2 and Phase 2b evidence, with Phase 3 now underway.

Weight-Loss Evidence

Strong Phase 2 evidence Mean weight loss reached approximately:

15.6% at 48 weeks in the 2.4 mg MOMENTUM arm.

Liver Evidence

Strong investigational evidence Human research demonstrates:

• large liver-fat reductions

• MASH-resolution activity

• improvements in liver-related biomarkers.

Alcohol-Use-Disorder Evidence

Promising Phase 2 topline evidence RECLAIM reported a significant reduction in heavy-drinking days.

Full peer-reviewed efficacy publication is still needed.

Overview

Pemvidutide is a long-acting investigational:

GLP-1 / glucagon dual receptor agonist being developed primarily for serious metabolic and liver diseases.

The GLP-1 component helps reduce:

appetite and food intake while glucagon-receptor activity is intended to provide additional:

liver and metabolic effects.

Human studies have shown:

• substantial weight loss

• very large liver-fat reductions

• significant MASH activity

and more recently:

• promising Phase 2 AUD results.

It nevertheless remains:

investigational.

Evidence Strength

Overall Evidence Rating

Strong human investigational evidence Strong evidence for

• dual GLP-1 / glucagon receptor activity

• once-weekly SC administration

• weight loss

• liver-fat reduction

• MASH activity

• GI adverse effects

Promising human evidence for

• alcohol-use-disorder outcomes

• fibrosis-related improvements

• broader cardiometabolic effects

Not established

• FDA-approved obesity treatment

• FDA-approved MASH treatment

• FDA-approved AUD treatment

• standard commercial dose

• universal titration schedule

• community-vial equivalence

• bodybuilding

• athletic enhancement

• anti-aging

• receptor-reset cycling

• stacking with other incretin agonists

Category

GLP-1 / Glucagon Dual Agonists • Metabolic Health • Liver Disease Research

Compound

Pemvidutide Development name:

AL T-801

Compound Type

Long-acting peptide GLP-1 / glucagon dual receptor agonist Pemvidutide is:

• peptide-based

• a GLP-1 receptor agonist

• a glucagon receptor agonist

• designed for weekly administration

It is not:

• a GIP agonist

• insulin

• a stimulant

• an approved medication

Primary Research Focus

Most Advanced

MASH with Phase 3 development now underway.

Human Research Also Includes

• obesity

• weight loss

• MASLD

• alcohol use disorder

• alcohol-associated liver disease.

Not Established

• bodybuilding

• athletic performance

• anti-aging

• general wellness

Human Clinical Research

Once weekly SC Evidence assessment Directly supported across the major human programs.

Possible Benefits

Weight Loss

Strong Phase 2 human evidence.

Liver Fat Reduction

Strong human clinical evidence.

MASH Improvement

Phase 2b human evidence supports meaningful MASH-resolution activity, with Phase 3 now underway.

Alcohol Use Disorder

Positive sponsor-reported Phase 2 topline evidence.

Important All remain:

investigational treatment indications unless and until regulatory approval occurs.

What It Does Not Help With, Based on Current

Evidence

Do not present pemvidutide as proven to:

• build muscle

• improve athletic performance

• selectively burn abdominal fat

• increase energy

• repair injuries

• treat type 2 diabetes as an approved therapy

• treat AUD as an approved medication

• treat ALD as an approved medication

• prevent weight regain after stopping

• provide identical results at every dose

Commonly Paired With

Metformin

Different primary mechanism.

Classification: Mechanistically nonredundant; combination claims require actual evidence.

Semaglutide

Significant GLP-1 overlap.

Classification: Major pathway overlap; no validated combination.

Tirzepatide

Shared GLP-1 signaling.

Classification: Major pathway overlap; no validated combination.

Retatrutide

Shared GLP-1 and glucagon signaling.

Classification: Highly redundant.

Cagrilintide

Different main pathway.

Classification: Less direct overlap, but no validated combination protocol.

Dosage Information

Clinical-Trial Pemvidutide

Route: Subcutaneous F requency: Once weekly Major studied doses

• 1.2 mg

• 1.8 mg

• 2.4 mg.

Important There is still no:

FDA-approved public pemvidutide dosing schedule.

Weight-Loss Research

Around 24 weeks Clinically meaningful weight loss and liver-related changes are measurable by this period.

Around 48 weeks MOMENTUM reported:

1.2 mg: 10.3% 1.8 mg: 11.2% 2.4 mg: 15.6%

mean weight loss.

Liver Research

12–24 weeks Large liver-fat reductions can occur during this period.

24 weeks Important biopsy-based MASH outcomes were assessed in the IMPACT program.

48 weeks Longer-term metabolic and fibrosis-related outcomes were reported.

Regulatory Status

United States

FDA approved?

No

Fast Track

MASH: Yes AUD: Yes

Breakthrough Therapy

MASH: Yes, granted January 5, 2026.

Phase 3

Underway PERFORMA began in August 2026.

What Studies Have Found

MOMENTUM Obesity

At 48 weeks:

1.2 mg: 10.3% mean weight loss 1.8 mg: 11.2% 2.4 mg: 15.6% Placebo: 2.2%.

Supports

• weekly SC dosing

• substantial weight loss

• genuine human dose-response research

Does not support

• an FDA-approved obesity dose

• universal 1.2 → 1.8 → 2.4 mg escalation

MASLD Research

At 24 weeks, relative liver-fat reductions were approximately:

1.2 mg: 56.3% 1.8 mg: 75.2% 2.4 mg: 76.4% Placebo: 14.0%.

Supports Strong human evidence for liver-fat reduction.

Does not support Calling pemvidutide:

a liver detox drug

IMPACT Phase 2b MASH

Phase 2b data showed significant:

MASH resolution without worsening fibrosis and additional fibrosis-related improvements over longer follow-up.

Supports Strong enough MASH activity to justify registrational Phase 3 development.

Does not support Claiming:

Pemvidutide has already proven fibrosis reversal in everyone.

RECLAIM Phase 2 AUD

RECLAIM used:

2.4 mg once weekly for:

24 weeks in approximately 100 participants.

Altimmune reported significant improvement in the primary heavy-drinking-day endpoint in July 2026.

Supports Promising human Phase 2 evidence for AUD.

Does not support Calling pemvidutide an approved AUD medicine.

PERFORMA Phase 3

Altimmune initiated the global:

PERFORMA Phase 3 MASH program on August 3, 2026.

Why this matters Pemvidutide should now be described as:

a late-stage investigational drug rather than simply:

an early experimental peptide.

No FDA-Approved Commercial Product Exists

There is no approved pemvidutide product providing one universal:

• concentration

• diluent

• reconstitution method

• refrigerated storage period

• 14-day use period

• 28-day use period

Research vials Community products may provide their own instructions for:

• bacteriostatic water

• refrigeration

• post-mixing use periods

Those are:

product/community handling instructions not:

validated clinical pemvidutide stability data.

Simple rule Use handling and stability information for the exact formulation.

Storage

Formulation / Stability / Sterility Logic

There is currently:

no FDA-approved commercial pemvidutide formulation.

Therefore there is no universal approved reference product defining:

• vial strength

• concentration

• diluent

• bacteriostatic-water use

• post-reconstitution storage

• 14-day use period

• 28-day use period

V erdict Use exact-product evidence only .

A research vial sold online is not automatically equivalent to the investigational clinical-trial product.

Formulation / Stability / Sterility

Contraindications & cautions

Safety at a Glance

Human Trial Safety

The most common adverse effects in the clinical program have been gastrointestinal, including:

• nausea

• vomiting

• diarrhea

• constipation

These effects have generally been described as mild to moderate in major trials.

MASH Program

Altimmune reported a favorable overall tolerability profile through 48 weeks in IMPACT, including low treatment-related discontinuation.

Important This is meaningful trial safety evidence.

But it is not equivalent to:

years of postmarketing safety data from an approved drug.

RECLAIM AUD Trial

RECLAIM also reported gastrointestinal effects such as nausea, vomiting, diarrhea and constipation in the 2.4 mg group. The topline results remain sponsorreported pending fuller publication.

Any isolated serious event from that trial should be described as an individual trial event , not automatically upgraded into a common pemvidutide adverse effect.

Formal Contraindications

None established through an FDA-approved product label Pemvidutide is not approved.

There is therefore no FDA-approved pemvidutide contraindication section.

Do not copy contraindications from:

• Wegovy

• Saxenda

• Zepbound

• other GLP-1 drugs

and present them as official pemvidutide contraindications.

Important Cautions

Pregnancy / Breastfeeding

Human safety has not been established.

Classification: Important investigational-use caution.

Significant Gastrointestinal Disease

Pemvidutide causes GI adverse effects in human trials.

Classification: Clinically relevant caution, not an FDA-established contraindication.

Other GLP-1 Drugs

Combining pemvidutide with another GLP-1 receptor agonist creates major pathway overlap.

Classification: Unvalidated combination.

Pancreatitis

A history of pancreatitis may be clinically relevant when evaluating an incretinbased investigational drug.

But pemvidutide does not currently have an approved label defining pancreatitis history as an official contraindication.

Classification Clinical caution, not formal pemvidutide contraindication

MTC / MEN2

Do not automatically import the medullary-thyroid-carcinoma / MEN2 contraindications from approved GLP-1 drugs.

Pemvidutide currently has no FDA-approved label establishing those as formal contraindications.

V erdict Do not present as official unless a future approved label specifically includes them.

Contraindications & Cautions

Formal Contraindications

None established in an FDA-approved label Because no FDA-approved pemvidutide label exists.

Important Cautions

Pregnancy / Breastfeeding Safety not established.

Significant GI Disease GI adverse effects occur in clinical trials.

Other GLP-1 Drugs Major pathway overlap.

Pancreatitis History Potentially relevant clinical caution, but not an official pemvidutide contraindication.

Thyroid Cancer / MEN2 Do not copy contraindications from other GLP-1 product labels and call them official pemvidutide contraindications.

Side effects

Reported Side Effects

Common Human-Trial Effects

Most commonly gastrointestinal:

• nausea

• vomiting

• diarrhea

• constipation.

Most have been described as mild to moderate.

Serious Events

Serious drug-related events have not dominated the clinical program.

However:

pemvidutide still lacks the long-term postmarketing safety history of an approved drug.

Compatibility

Stack / Pairing Logic

Pemvidutide + Semaglutide

Both activate GLP-1 receptors.

V erdict: Major pathway overlap; no validated combination.

Pemvidutide + Tirzepatide

Tirzepatide activates:

• GLP-1

• GIP

Pemvidutide activates:

• GLP-1

• glucagon

V erdict: Major GLP-1 overlap; combination unvalidated.

Pemvidutide + Retatrutide

Retatrutide activates:

• GLP-1

• GIP

• glucagon

That overlaps with both main pemvidutide targets.

V erdict: Very high pathway redundancy; no validated combination.

Pemvidutide + Cagrilintide

Cagrilintide primarily acts through amylin-related pathways.

V erdict: Less direct receptor overlap, but no validated pemvidutide combination protocol.

Pemvidutide + Metformin

Different primary mechanisms.

V erdict: Mechanistically nonredundant, but specific use should be based on actual clinical evidence rather than assumptions.