Metabolic · Dosing reference

Pemvidutide dosage

Doses given in registered human trials, how long they ran, and the arithmetic for working with vials.

InvestigationalAHuman trial evidenceTrial doses

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Regulatory status: Investigational
Human amounts: 1.2, 1.8 or 2.4 mg once weekly without titration (phase 1 MASLD, 12–24 weeks); 1.2 or 1.8 mg (IMPACT phase 2b); phase 3 PERFORMA registered at 1.8 and 2.4 mg
Route studied: Subcutaneous injection
Frequency: Once weekly
Half-life: A numerical human half-life was not located in the sources reviewed
Evidence grade: Grade A · Human trial evidence
Vial sizes on the market: Not recorded
Other forms seen: —

What Pemvidutide is

Pemvidutide (ALT-801) is an investigational once-weekly peptide that activates both the GLP-1 and glucagon receptors with closely matched potency. It has been studied in randomized placebo-controlled trials in fatty liver disease, and a phase 3 trial in MASH was registered in 2026. It is not an approved medicine, and this entry is for research information only.

Pemvidutide (ALT-801) is described as a dual GLP-1 receptor (GLP-1R) and glucagon receptor (GCGR) peptide agonist conjugated to a glycolipid moiety that slows absorption into the plasma and prolongs half-life ^4. Balanced receptor potency The preclinical report gives closely matched potencies of 39 pM at GLP-1R and 42 pM at GCGR, and contrasts this with other dual agonists that the authors describe as biased towards… How it works →

Key evidence

Harrison et al., J Hepatol · 2025 · Humans (94 adults with MASLD and BMI of 28 or more; 29% with type 2 diabetes)
Relative liver-fat reductions were 46.6%, 68.5% and 57.1% at 1.2, 1.8 and 2.4 mg versus 4.4% with placebo; at 1.8 mg, 94.4% reached a 30% reduction and 55.6% reached normal liver fat (5% or less), and body weight fell by 4.3% ^1. ¹
Browne et al., JHEP Rep · 2025 · Humans (64 completers of the parent MASLD trial)
Relative liver-fat reductions were 56.3%, 75.2% and 76.4% versus 14.0% with placebo; at 1.8 mg, 84.6% reached a 50% reduction and body weight fell by 6.2% ^2. ²
Noureddin et al., Lancet (IMPACT) · 2025 · Humans (212 adults with biopsy-confirmed MASH, fibrosis F2-F3)
MASH resolution without fibrosis worsening occurred in 58% (1.2 mg) and 52% (1.8 mg) versus 20% with placebo; fibrosis improvement without MASH worsening was 33% and 36% versus 28% and did not differ significantly from placebo ^3. ³

All studies on the research page

Schedules by time period

study arms from registered trials, laid out week by week. Each bar is what the label states or what investigators gave participants; none is a recommendation.

Registered trial

Phase 2b IMPACT (NCT05989711): study arms ³

Adults with biopsy-confirmed MASH and fibrosis stage F2 or F3 (212 randomized) · 48 weeks

1.2 mg

SC · once weekly

Week-by-week table

Period	Amount
Weeks 0–48	1.2 mg (maintenance)

1.8 mg

SC · once weekly

Week-by-week table

Period	Amount
Weeks 0–48	1.8 mg (maintenance)

Pemvidutide was administered once weekly subcutaneously without dose titration. IMPACT is a 48-week trial; the cited report covers the 24-week primary analysis.

Doses given in human trials

In the phase 1 MASLD trial (NCT05006885), participants were randomized 1:1:1:1 to once-weekly subcutaneous pemvidutide at 1.2 mg, 1.8 mg or 2.4 mg, or placebo, for 12 weeks ^1.
In the extension trial (NCT05292911), completers continued their originally assigned dose without titration for a further 12 weeks ^2.
In IMPACT (NCT05989711), participants were randomized 1:2:2 to once-weekly subcutaneous pemvidutide 1.2 mg or 1.8 mg, given without dose titration, or placebo ^3,12.
The PERFORMA phase 3 registration (NCT07795164) lists pemvidutide 1.8 mg and 2.4 mg and placebo arms, an estimated enrolment of 1,800 and histological endpoints at week 52 ^6.
In the phase 1 MASLD trial, 94 participants were randomized and dosed ^1; 64 completers entered the 12-week extension ^2.
IMPACT randomized 212 participants with biopsy-confirmed MASH and fibrosis stage F2 or F3: 41 to pemvidutide 1.2 mg, 85 to 1.8 mg and 86 to placebo ^3.
The MOMENTUM obesity trial registry record (NCT05295875) lists three ALT-801 (pemvidutide) dose levels and placebo, 391 participants enrolled and a week-48 body-weight primary endpoint; dose amounts are not stated in the registry fields and no results are posted ^5.
The RECLAIM phase 2 registry record (NCT06987513) lists pemvidutide 2.4 mg versus placebo in 100 participants with alcohol use disorder and obesity or overweight, with the primary endpoint over weeks 21–24 ^7.
The RESTORE phase 2 registry record (NCT07009860) lists pemvidutide 2.4 mg versus placebo in 121 participants with alcohol-associated liver disease, with liver-stiffness endpoints at weeks 24 and 48 ^8.

How long did human studies run?

Phase 1 MASLD trial: 12 weeks; extension: a further 12 weeks at the same dose (24 weeks in total) ^1,2.
IMPACT is a 48-week trial with dual primary endpoints at 24 weeks ^3. PERFORMA lists histological endpoints at week 52 and a clinical-outcomes endpoint through approximately month 60 ^6.

Cycle-length evidence for Pemvidutide

Who was excluded from the studies

IMPACT registry exclusion criteria include weight change of more than 5% in the 3 months before randomization or more than 10% in the 6 months before screening, type 1 diabetes, HbA1c above 9.5%, history of cirrhosis or its complications, other causes of chronic liver disease, and ALT or AST above 5× ULN ^12.
The phase 1 MASLD trial enrolled participants with BMI of 28.0 or higher and liver fat content of at least 10% by MRI-PDFF ^1.

Side effects reported in studies

Any adverse event
78% (1.2 mg) and 81% (1.8 mg) versus 67% placebo · IMPACT, adults with MASH F2-F3, 24 weeks ³
Discontinuation due to adverse events
0% (1.2 mg) and 1% (1.8 mg) versus 2% placebo · IMPACT, 24 weeks ³
Severe or serious adverse events
None reported · Phase 1 MASLD trial, 12 weeks ¹
Nausea
33.3% of pemvidutide recipients during the extension phase · MASLD extension trial (weeks 12-24) ²
Discontinuation due to adverse events
2 of 16 (1.2 mg) and 1 of 15 (1.8 mg); none with 2.4 mg or placebo · MASLD extension trial ²

Full adverse-event data

Pemvidutide draw calculator

Pick the vial strength and the water added, enter an amount, and see the concentration, the units to draw and how many draws the vial holds. Arithmetic only.

1 · Vial strength

2 · Water added

3 · Amount per draw

4 · Syringe

Your mix

10 mg + 2 mL water = 5 mg/mL

10 units holds 0.5 mg (500 mcg)

Draw toEnter an amount in step 3

U-100 syringe · 100 units = 1 mL

Computed from your inputs. Not a dose or a recommendation.

Compare water volumes for this vialShow

More water = lower concentration = a larger, easier-to-measure draw. Tap a row to use it.

Water	mg/mL	Draw
0.5 mL	20	—
1 mL	10	—
1.5 mL	6.667	—
2 mL	5	—
2.5 mL	4	—
3 mL	3.333	—
5 mL	2	—

Supplies and handling

Lyophilized vial
Sealed vial with the freeze-dried cake. Check the label, lot and the certificate of analysis before opening.
Sterile diluent
The diluent named on the product documentation. Bacteriostatic water contains benzyl alcohol; sterile water does not.
Graduated syringes
Sized to the volume being measured. U-100 insulin syringes are graduated in units where 100 units = 1 mL.
Alcohol prep pads
For wiping vial stoppers before each puncture.
Nitrile gloves
Clean gloves for aseptic handling.
Sharps container
Puncture-resistant container for used needles.

Step-by-step reconstitution guide Storage and transport accessories

Storage

Storage conditions for research material are set by the supplier's documentation; lyophilized peptides are generally sensitive to heat, light and moisture.

Lyophilized (unmixed) vials: typically stored cold and dry, away from light, as the documentation directs. Many are stable longer frozen.
Reconstituted vials: typically refrigerated (about 2–8 °C), protected from light and not frozen.
Bacteriostatic water contains benzyl alcohol, which inhibits bacterial growth in multi-use vials; sterile water has no preservative.

Handling mistakes and troubleshooting

Added the wrong volume of diluent: The concentration changes, not the amount of compound in the vial. Recalculate with the volume actually added and relabel the vial.
Shook the vial and it foamed: Let it settle in the refrigerator. Foam is a sign of agitation; some peptides aggregate when shaken. Note it on the label.
The solution is cloudy or has particles: Do not use it. Cloudiness can indicate incomplete dissolution, contamination or degradation. Record the lot and contact the supplier with the certificate of analysis.
The powder cake looks melted or shrunken before reconstitution: This can indicate the vial was exposed to heat or moisture. Record the lot and condition on arrival.
Liquid sprayed back when the needle was removed: Pressure built up in the vial. Withdraw a small volume of air while adding diluent to keep pressure neutral.

Regulatory status

Status: Investigational as of 22 October 2026. An openFDA query of Drugs@FDA on that date returned no application record for pemvidutide ^9, and a phase 3 trial in MASH is registered as recruiting ^6.
United States (FDA): Pemvidutide is investigational; an openFDA query of Drugs@FDA application data on 22 October 2026 returned no application record for it ^9.
Sport (WADA): Pemvidutide is not named in the 2026 Prohibited List text reviewed. Section S0 covers pharmacological substances not addressed elsewhere on the List that have no current approval by any governmental regulatory health authority for human therapeutic use, including drugs under clinical development; athletes should consult WADA directly ^10.

Status varies by country and changes over time. How we describe regulatory status.

Pemvidutide compared with related compounds

Compound	Status	Evidence	Human amounts	Half-life
Pemvidutide	Investigational	A	Trial doses	A numerical human half-life was not loca
Tesofensine	Investigational	B	Trial doses	About 234 hours (M1 metabolite about 374
Mazdutide	Approved outside the US	A	Trial doses	150.9 to 403.5 hours (phase 1b in overwe
Cagrilintide	Investigational	A	Trial doses	159 to 195 hours (phase 1b, co-administe
SLU-PP-332	Not approved — research use only	C	None established	Unknown in humans
MariTide (maridebart cafraglutide)	Investigational	A	Trial doses	Not reported numerically in the sources

Frequently asked questions

What doses of Pemvidutide have been studied in humans?

Pemvidutide is investigational. This page lists the amounts given in each cited trial as facts about those studies.

Is there an established Pemvidutide cycle length?

No cycle length or break has been established. Human studies administered Pemvidutide for the periods listed on this page; those are study durations, not a recommended course.

How much bacteriostatic water should be added to a Pemvidutide vial?

There is no compound-specific volume. The diluent volume only sets the concentration: concentration = mass in the vial ÷ volume added (for example, 10 mg in 2 mL gives 5 mg/mL). The calculator on this page shows the arithmetic for any combination.

How many units is a given amount on an insulin syringe?

On a U-100 syringe, 100 units = 1 mL. Units for an amount = amount ÷ (concentration per unit). The calculator converts any amount you enter at the concentration you choose; a unit is a volume mark, not an amount of compound.

What is the half-life of Pemvidutide?

A numerical human half-life was not located in the sources reviewed

Is Pemvidutide FDA-approved?

Investigational. Investigational as of 22 October 2026. An openFDA query of Drugs@FDA on that date returned no application record for pemvidutide ^9, and a phase 3 trial in MASH is registered as recruiting ^6.

References

Last reviewed October 23, 2026 by the Amiravo editorial team. Editorial policy · Report an error