Protocols
Retatrutide protocols in the published literature
StatusPhase 3 · not FDA approved
PeptideHound Staff · Last editorially reviewed · 12 sources
Retatrutide — reta, in the way most people search for it — is an investigational compound, which means no regulator has approved it and there is no label to quote from. Everything published about amounts comes out of registered trials, and that is what this page reports.
The figures people are looking for come from a 48-week phase 2 trial in adults with obesity. Participants were randomly assigned in a 2:1:1:1:1:2:2 ratio to receive subcutaneous retatrutide (1 mg, 4 mg [initial dose, 2 mg], 4 mg [initial dose, 4 mg], 8 mg [initial dose, 2 mg], 8 mg [initial dose, 4 mg], or 12 mg [initial dose, 2 mg]) or placebo once weekly for 48 weeks. By week 48 the average change in body weight ran from -8.7% in the 1-mg group to -24.2% in the 12-mg group.
That is a long way into people, further than almost anything else covered on this site. A phase 3 trial in type 2 diabetes has now reported, and it assigned 537 adults to 4 mg, 9 mg or 12 mg once weekly against placebo for 40 weeks. Read those numbers for what they are. They are randomly assigned targets, reached under supervision, using material whose identity and strength were known to the investigators. No published work carries them across to a vial bought outside that setting, and this page does not make the step either.
Because nothing is approved, there is no labelled strength, no titration schedule and no pharmacy price anywhere on the record. What the FDA record does hold is an enforcement entry for Retatrutide for Injection, 60mg / 10mL vial, all presentations, recalled for lack of assurance of sterility.
Evidence: Not dosing guidance · no approved label and no established human amount · published trial arms ran from 0.5 mg to 12 mg once weekly · longest published course 48 weeks · nothing has been validated for an unlabelled vial
What amounts of retatrutide were used in the trials?
human RCT
There is no approved amount of retatrutide, because no regulator has approved the compound for anything, so nothing below is a labelled figure. What the published record holds instead is a set of randomly assigned trial arms. The obesity trial is the clearest of them. Participants were randomly assigned in a 2:1:1:1:1:2:2 ratio to receive subcutaneous retatrutide (1 mg, 4 mg [initial dose, 2 mg], 4 mg [initial dose, 4 mg], 8 mg [initial dose, 2 mg], 8 mg [initial dose, 4 mg], or 12 mg [initial dose, 2 mg]) or placebo once weekly for 48 weeks.1 The diabetes programme reached lower and ended higher. A phase 2 trial administered retatrutide maintenance doses of 0·5 mg, 4 mg (starting dose 2 mg), 4 mg (no escalation), 8 mg (starting dose 2 mg), 8 mg (starting dose 4 mg), or 12 mg (starting dose 2 mg)2, and a 2026 phase 3 trial assigned adults to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection7. Those arms span a twenty-four-fold range because they were built to map a dose-response curve, not to describe a working amount. We report them as the trial protocols they are, and we publish no conversion from any of them to anything a reader could apply.
| Trial | Weekly amounts studied | Starting amount where stated |
|---|---|---|
| Obesity trial, 48 weeks | 1, 4, 8 or 12 mg, or placebo | 2 mg or 4 mg for the 4 mg and 8 mg arms; 2 mg for the 12 mg arm |
| Phase 2 diabetes trial | 0·5, 4, 8 or 12 mg | 2 mg or 4 mg for some arms; one 4 mg arm with no escalation |
| 2026 phase 3 trial | 4, 9 or 12 mg, or placebo | Not stated |
Is there a retatrutide dosing schedule?
human RCT
Every registered trial settled on the same rhythm, and that rhythm is the one piece of this that holds across the whole programme. The phase 2 obesity trial gave retatrutide or placebo once weekly for 48 weeks, the liver substudy inside it assigned participants (n = 98) to 48 weeks of once-weekly subcutaneous retatrutide (1, 4, 8 or 12 mg dose) or placebo3, and the 2026 phase 3 trial ran 40 weeks at 48 sites in the USA, Mexico, and India7. Within that rhythm the arms climbed rather than starting where they finished. The obesity trial carried two different opening amounts into its 4-mg and 8-mg groups, and reported that gastrointestinal events were partially mitigated with a lower starting dose (2 mg vs. 4 mg)1. A 2025 review of this whole class observes that such effects can often be mitigated by slow up titration, meaning a gradual climb5. A climb written by investigators to reach a randomly assigned target is not a schedule issued to anybody, and no published work turns the first into the second.
How much retatrutide to start, and is 1 mg a week enough?
human RCT
The smallest arm published in obesity was 1 mg once weekly, and it was there to anchor the bottom of the dose-response curve rather than as a destination. At 24 weeks the least-squares mean percentage change in body weight in the 1-mg group was -7.2%, against -1.6% in the placebo group, and by 48 weeks that group had reached -8.7%.1 The diabetes programme went lower still, carrying a 0·5 mg maintenance arm alongside the larger ones.2 So 1 mg a week did something measurable in that group, roughly a third of the percentage recorded in the 12-mg group over the same period. Whether that counts as enough is a question about a particular individual rather than about a protocol, and no published work answers it at that level. Starting figures are also distinct from assigned figures, which is where most of the confusion begins. Participants entering the 4-mg and 8-mg groups opened at either 2 mg or 4 mg and escalated from there, supervised by investigators throughout.1
Can you take more than 12 mg of retatrutide?
human RCT
Twelve milligrams once weekly is the ceiling of the published record, and it is the ceiling of every registered trial rather than of a particular one. The obesity trial stopped there, the liver substudy stopped there with arms of 1, 4, 8 or 12 mg3, and the 2026 phase 3 trial stopped there after assigning 134 adults to retatrutide 4 mg, 133 to retatrutide 9 mg, 136 to retatrutide 12 mg, and 134 to placebo7. Searches for 40 mg of retatrutide therefore have no published counterpart. That is not a verdict on what 40 mg would do, because nobody in this record has run it and published the measurement. It means no experiment covered here exists to report, and an amount without an experiment behind it is not a larger version of an amount that has one. The 9-mg assignment deserves separate attention. It appears only in phase 3, which is where dose selection had already been narrowed using the earlier evidence.2
How was retatrutide given, and how often?
human RCT
Under the skin, once a week, in every registered trial that has published a protocol. The 2026 phase 3 trial assigned its participants to receive retatrutide (4 mg, 9 mg, or 12 mg) or placebo by once-weekly subcutaneous injection7, and that same route and weekly interval run through the earlier work as well. A phase 1 study on the trial registry lists adults with type 2 diabetes on Once-Weekly Retatrutide.12 No source among the research behind this page describes a tablet, a patch, a nasal spray or a daily shot, and that silence is a gap in the record rather than a finding about those routes. The whole programme has been built around one weekly injection, from the earliest studies through to phase 3, and two large registered trials carry that design into obesity. One of them is listed as completed in participants who have obesity or overweight10, and a separate registry entry compares retatrutide with semaglutide in adults with type 2 diabetes and inadequate glycemic control with metformin11. Route and timing are the two parameters we can report with no arithmetic attached, because neither of them changes when the amount in the syringe does.
How much BAC water do you mix with 10 mg of retatrutide?
regulatory action
Reconstitution is arithmetic, and the arithmetic is identical regardless of which compound is involved. A 10 mg vial contains 10,000 micrograms of powder before anything is added, so 1 mL of bacteriostatic water leaves the concentration at 10,000 micrograms per mL, 2 mL leaves it at 5,000 micrograms per mL, and 5 mL leaves it at 2,000 micrograms per mL. A 5 mg vial contains 5,000 micrograms, a 6 mg vial 6,000, a 12 mg vial 12,000 and a 15 mg vial 15,000, each dividing the same way. The diluent volume establishes concentration and nothing beyond it. It does not alter the quantity of compound sitting in the glass, and it cannot resolve the second half of the calculation, which is the quantity anybody would eventually draw.8 Vial presentations in circulation are a matter of public record rather than of published literature. One FDA enforcement entry covers Retatrutide for Injection, 60mg / 10mL vial, all presentations, withdrawn for lack of assurance of sterility.8
How long does a 10 mg vial of reta last?
human RCT
Two separate questions are folded into that one, and only a single one of them currently has an answer. How long reconstituted material survives as chemistry is unaddressed anywhere in the published literature on this compound, so there is no storage interval available to report. How many individual draws a vial contains is arithmetic, and it stalls at precisely the same place every time. A 10 mg vial contains 10,000 micrograms however it is diluted, so the number of draws depends entirely on the quantity per draw. In the research behind this page, that quantity has not been established outside a registered trial, and inside those trials it was allocated at random to groups rather than selected for an individual.7 What the published protocols do establish is the interval between injections. Administration ran once weekly for 48 weeks in obesity, and for 40 weeks in the 2026 phase 3 diabetes trial, which describes a frequency rather than a quantity.1
How many clicks is 1 mg on a retatrutide pen?
human RCT
No source among the research behind this page describes a retatrutide pen, its click increments or any device marking, because no such device has been approved and the trials delivered assigned amounts rather than counted clicks.7 A click count that circulates without a device behind it is a number about somebody else's hardware. The arithmetic underneath it is reportable, and it is where most dosing errors actually happen. One milligram is a thousand micrograms, so a 10 mg vial holds 10,000 micrograms whatever volume it is dissolved in. Millilitres measure the liquid, milligrams measure the compound, and concentration is the only bridge between them. A U-100 insulin syringe is marked in units rather than millilitres, and because one hundred units make a millilitre, each unit mark is one hundredth of a millilitre. Our converter and reconstitution tools run those sums on the figures you enter, and neither of them carries a suggested amount.
How much weight came off per week in the trials?
human RCT
Nobody measured a weekly figure, which is the essential thing to understand about every per-week number circulating for this compound. The obesity trial established that its primary end point was the percentage change in body weight from baseline to 24 weeks, and it reported again at 48 weeks.1 Between those measurements the published record is silent. What it does report is the measurements themselves. At 48 weeks the least-squares mean percentage change was -8.7% in the 1-mg group, -17.1% in the combined 4-mg group, -22.8% in the combined 8-mg group, and -24.2% in the 12-mg group, against -2.1% on placebo.1 A subsequent analysis summarised the identical result as weight reductions of 22.8% and 24.2% with retatrutide 8 and 12 mg, respectively.3 Dividing 24.2% across 48 weeks produces a tidy number and an inaccurate one. Weight change in these participants was never linear, and an arithmetic average is not a weekly expectation.
How much weight can you lose in 3 months or 6 months on retatrutide?
human RCT
Twenty-four weeks approximates six months closely enough to answer the second half of that question directly. In the obesity trial the mean change in body weight at 24 weeks was -7.2% in the 1-mg group, -12.9% in the combined 4-mg group, -17.3% in the combined 8-mg group, and -17.5% in the 12-mg group, compared with -1.6% on placebo.1 The 2026 phase 3 trial measured the percentage change in bodyweight from baseline to week 40 as a key secondary endpoint.7 Three months carries no published figure, in any registered trial, at any assignment. These experiments were constructed to report at particular measurement points, and twelve weeks was never one of them, so a three-month percentage would have to be interpolated rather than read. A second consideration applies to the six-month figures. Participants spent a substantial portion of that window escalating toward their allocated amount, so the group average covers a period during which the majority were receiving considerably less.1
How long is a retatrutide cycle, and should you come off it?
systematic review
No registered trial among these sources has tested a cycle, a break or a taper, so there is no interval to report and no off-period anybody has measured. The longest published course is 48 weeks of weekly dosing, and the 2026 phase 3 trial ran 40 weeks the same way.1 A completed phase 3 entry on the registry covers people with obesity and heart disease.9 The literature is asking the opposite question, which is the useful part of this answer. A 2025 review of the class states that the outstanding question is maintenance of the weight loss, possibly pharmacological treatment needs to be life-long.5 A 2025 systematic review lists long-term follow-up data on safety and efficacy of weight maintenance among the evidence still needed.4 Read what that implies about cycling. Investigators are not studying how to come off these compounds, because the problem they describe is what happens when people do. That is a statement about an open question rather than a reason to keep going or to stop.
How much does retatrutide cost?
systematic review
No source among the research behind this page reports a price, and the reason is structural rather than an oversight. Retatrutide is one of fourteen ongoing phase 3 programmes catalogued in a 2025 systematic review, and that review notes that oral semaglutide 50 mg is the only medication among the emerging agents to have completed a phase 3 trial.4 Until a compound is approved there is no list price, pharmacy price or reimbursement figure for anyone to report. Cost is an open question in the literature as well. The same systematic review lists cost-effectiveness assessments among the gaps that need closing, and a 2025 review of retatrutide specifically says considerations regarding cost warrant further investigation.6 Figures quoted elsewhere come from sellers rather than from any published record, and we have no way to check them. The only number on the public record is a packaging one: a 60mg / 10mL vial withdrawn for sterility reasons.8
Why do the published amounts vary so much?
human RCT
Because the trials were built to find out what the amounts do, not to apply an amount already understood. The phase 2 obesity trial says exactly that at the opening of its own report, stating that its dose-response relationships with respect to side effects, safety and efficacy were not known when it began.1 That is why the arms are spaced the way they are. Running 1 mg alongside 12 mg in a single trial is how a dose-response curve gets drawn, and the phase 2 diabetes trial made the purpose explicit, recording that these phase 2 data also informed dose selection for the phase 3 programme2. Phase 3 then narrowed to 4, 9 and 12 mg. Populations differ as well, which moves the figures again. Obesity, type 2 diabetes and fatty liver disease were studied in separate trials, and a 2025 review notes dose-dependent effects on body weight, blood sugar and liver fat across phase 1 and phase 26.
What we don’t know
The gaps in the evidence matter as much as the findings.
- 01What any of these amounts mean for an unlabelled vial. Every published figure was assigned inside a trial, with the strength and identity of the material known in advance.
- 02What happens above 12 mg. No registered trial we cite has published an arm higher than that, so figures like 40 mg have no published counterpart at all.
- 03What a week-by-week curve looks like. The trials reported body weight at 24, 40 and 48 weeks, and no analysis among the research behind this page breaks the loss down by week.
- 04Whether stopping, cycling or tapering changes anything. No trial among the research behind this page tested a break, and the open question in the literature runs the other way, toward how long people would stay on it.
- 05What it costs. No source among the research behind this page reports a price for retatrutide, and reviews list cost-effectiveness as something still to be worked out.
- 06How much goes in a vial sold outside a trial. No analysis among the research behind this page has measured the identity, strength or sterility of material sold as retatrutide.
- 07Whether the escalation used in trials has any bearing elsewhere. It was run by investigators against a randomly assigned target, and no paper we could find has published that comparison.
- 08What long-term exposure does. The longest published course is 48 weeks, and no published follow-up goes beyond the end of the trials.
Sources
- 1Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial N Engl J Med 2023. doi:10.1056/NEJMoa2301972human RCT
- 2Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA Lancet 2023. doi:10.1016/S0140-6736(23)01053-Xhuman RCT
- 3Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial Nat Med 2024. doi:10.1038/s41591-024-03018-2human RCT
- 4Emerging pharmacotherapies for obesity: A systematic review Pharmacol Rev 2025. doi:10.1124/pharmrev.123.001045systematic review
- 5The promise of glucagon-like peptide 1 receptor agonists (GLP-1RA) for the treatment of obesity: a look at phase 2 and 3 pipelines Expert Opin Investig Drugs 2025. doi:10.1080/13543784.2025.2472408review
- 6Retatrutide-A Game Changer in Obesity Pharmacotherapy Biomolecules 2025. doi:10.3390/biom15060796review
- 7Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial Lancet 2026. doi:10.1016/S0140-6736(26)00967-0human RCT
- 8Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692 sourceregulatory action
- 9A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease NCT05882045registered trial
- 10A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight NCT05929066registered trial
- 11Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2) NCT06260722registered trial
- 12A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia NCT06982846registered trial
