Protocols
Semaglutide protocols in the published literature
StatusFDA approved
PeptideHound Staff · Last editorially reviewed · 24 sources
Semaglutide is one of the few compounds on this site with an approved label, so its amounts are figures a regulator published, not a view of ours about what anyone should take. A 2021 Lancet trial refers to semaglutide 1·0 mg (the dose approved for diabetes treatment), and 2.4 mg/week is the amount approved for weight loss as Wegovy.
A 2023 review covers the safety of semaglutide 2.4 mg/week for obesity, the amount behind what a 2022 review records as Food and Drug Administration approval of Wegovy (semaglutide) for weight loss. They were not picked out of the air either. The 2021 obesity trial assigned 1961 adults, in a 2:1 ratio, to 68 weeks of treatment with once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo. An earlier diabetes trial had given once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg) for 30 weeks, and a 2025 trial went further still, to semaglutide 7·2 mg, 2·4 mg, or placebo for 72 weeks.
What an approval does not do is travel. The approved schedule belongs to the approved product, and a compounded or research-grade vial has no approved label, so nothing in that schedule has been established as applying to what is inside it. We publish no step across from one to the other, because that step is the thing no study we cite has validated.
That distinction is not a technicality. FDA enforcement records hold ten Class II recalls of semaglutide. Five cite lack of assurance of sterility, two cite lack of processing controls, one records a subpotent vial, and one covers bulk powder sold for compounding use.
Evidence: Not dosing guidance · the approved weight-management amount is 2·4 mg once weekly and the approved diabetes amount is 1·0 mg once weekly · trial assignments reported as trial parameters · compounded and research-grade vials carry no approved label and nothing below has been established as applying to them
What does the FDA-approved label cover for semaglutide?
human RCT
Two approvals, two amounts, and telling them apart is the first job on this page. A 2021 trial in the Lancet refers to semaglutide 1·0 mg (the dose approved for diabetes treatment).3 That is the weekly injected amount tied to type 2 diabetes; the weight-management approval came later. A 2022 review records that the STEP results led to Food and Drug Administration approval of Wegovy (semaglutide) for weight loss.6 A 2023 review covers the safety of semaglutide 2.4 mg/week for obesity, and a JAMA review the same year lists it among six medications currently approved by the US Food and Drug Administration for long-term use.710 We report it for the same reason we report that a compound is not approved for anything: it is a statement about what a regulator decided, rather than a view of ours.
What is actually on a semaglutide dosing chart?
review
Most charts online are a ladder of weekly amounts with dates beside them, laid out as though one sequence fitted everybody. The published record is narrower, and it comes in pieces that are easy to run together. The injected amounts in phase 3 reports are 0·5 mg, 1·0 mg, 2·4 mg and 7·2 mg once weekly. A 2022 review places the first two: the SUSTAIN and PIONEER clinical trials studied the use of 1.0 mg, once-weekly, subcutaneous and oral semaglutide (a new GLP-1 homolog), respectively, on participants with type 2 diabetes.6 The same review records that the STEP trial examined the effects of 2.4 mg, once-weekly, subcutaneous semaglutide on patients with obesity.6 A chart carrying those numbers reports an approval beside a set of trial assignments, two different kinds of statement, and a chart that continues past them reports neither.
What was the starting amount in the trials?
human RCT
Nobody in the published programme began where they finished, but these reports name the assigned target far more often than the steps leading up to it. The lowest injected arm anywhere in the phase 3 record is 0·5 mg. In the 2017 diabetes trial, participants were given once-weekly subcutaneously injected semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo, for 30 weeks.1 The weight-management trials arrived at their target the same way: the 2021 obesity trial took 1961 adults and assigned them, in a 2:1 ratio, to 68 weeks of treatment with once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo.2 What these papers therefore supply is an assignment and a duration, rather than a week-by-week chart anybody could lift off the page. The sequence a prescriber follows belongs to a label, and a label is not what a trial report is.
What is the maximum dose of semaglutide?
human RCT
Higher than most charts show, and the ceiling differs by route. A 2025 phase 3b trial assigned people (5:1:1) to receive once-weekly subcutaneous semaglutide 7·2 mg, 2·4 mg, or placebo, with a lifestyle intervention, for 72 weeks.17 That 7·2 mg arm is the largest injected amount in the published record. By mouth the numbers run on another scale. A 2025 trial frames its own design that way, noting that oral semaglutide at a dose of 25 mg may provide an alternative treatment option to injectable semaglutide (2.4 mg) and higher-dose oral semaglutide (50 mg) for persons with overweight or obesity.16 Read those figures as research amounts rather than as a ceiling anybody has cleared. What an investigation was willing to assign, under supervision and with material of known identity, is a different question from what a label covers.
What amount was used for weight loss?
human RCT
2·4 mg once weekly, in trial after trial, across four continents and ten years. The two-year trial assessed the efficacy and safety of once-weekly subcutaneous semaglutide 2.4 mg versus placebo (both plus behavioral intervention) for long-term treatment of adults with obesity.8 A 2024 trial in a mostly east Asian group gave a subcutaneous injection of either semaglutide 2·4 mg or placebo once a week for 44 weeks.11 One trial put the weight amount against the diabetes amount directly, giving semaglutide 2·4 mg, or semaglutide 1·0 mg, or visually matching placebo, once a week for 68 weeks.3 That last design is the useful one, because it holds everything else still and varies only the amount. It is also the clearest demonstration that the two approved figures were tested as separate propositions rather than two rungs of one ladder.
How often was semaglutide given, and by what route?
systematic review
Once a week under the skin, or once a day by mouth, and nothing else shows up in the published record. A 2021 review notes that it is the only GLP-1RA currently available as both subcutaneous and oral formulation.5 GLP-1RA stands for glucagon-like peptide-1 receptor agonist, the family it belongs to. The oral route carries conditions the injection does not. A 2024 systematic review reports that food and various dosing conditions including water volume and dosing schedules can affect the oral semaglutide exposure, meaning how much of a tablet reaches the blood.12 Nothing among the research behind this page compares one injection site with another, splits a weekly amount across two days, or tries a different interval. Those are not questions the literature has answered badly; they are questions no study we could find has put to it, which amounts to an absence of investigation rather than an absence of effect.
Where was semaglutide injected, and at what time of day?
human RCT
The 2017 diabetes trial is the single report in this literature that describes the practice at all. Participants did their own injections and were encouraged to administer them on the same day of each week in the same area of their body; the time of day and proximity of meal times was not specified.1 Read that closely, because it settles two separate questions simultaneously and in opposite directions. Keeping to one area of the body was an instruction handed to participants, while the hour of the day was deliberately left open, which means the investigation was never constructed to establish whether either one matters. So the published record contains no comparison of one site against another, nor of morning against evening. Those are different questions from the one that trial asked, and neither has since been put to an investigation of its own.
What is the schedule for semaglutide tablets?
human RCT
Once a day, at two amounts in the published record. The heart outcomes trial is comparing oral semaglutide (14 mg once daily) with placebo, both in addition to standard of care, and 9650 participants were enrolled.9 The 2025 obesity trial gave oral semaglutide (25 mg) or placebo once daily, plus lifestyle interventions, in a 2:1 split.16 A registered phase 1 study sets out to compare how much semaglutide is found in the blood with different tablets of oral semaglutide in healthy participants.24 That is the question a tablet raises and a weekly injection does not. Those milligram figures do not line up against the injected ones. 25 mg daily by mouth and 2·4 mg weekly by injection describe two separate routes, measured separately, and setting them in one column manufactures a comparison no study among the research behind this page has published.
Does the amount depend on body weight?
systematic review
Not in any published schedule, and the review that looked hardest at the question stops short of saying so. A 2024 systematic review reports that body weight may affect semaglutide exposure, but further studies are needed to confirm this.12 The same review is far more definite in the other direction. It records limited drug-drug interactions and no dosing adjustments in patients with upper gastrointestinal disease, renal impairment or hepatic impairment, which covers the gut, the kidneys and the liver in one line.12 So there is no milligram-per-kilogram figure to report, and we would not publish one anyway. A per-kilogram conversion is how an animal amount gets dressed up as a human one, and here the human figures are already on the record rather than inferred from a mouse.
What does microdosing semaglutide mean?
human RCT
It means using amounts below the ones that were studied, and no trial among the research behind this page has tested one. The smallest injected arm in the phase 3 record is 0·5 mg once weekly, from the 2017 trial that gave semaglutide (0·5 mg or 1·0 mg), or volume-matched placebo, for 30 weeks.1 Below that figure the published literature is empty. Routine care is a separate matter: a 2025 review of practice outside trials records the use of much lower doses than those evaluated in clinical trials, alongside high discontinuation rates of GLP-1RAs (20%-50%) within the first year.13 Read those two findings together rather than apart, because that review is describing what people did in ordinary practice, not an amount anybody assigned, measured and followed up. A microdosing chart borrows the authority of the second while only ever describing the first.
Is there a dosing chart for compounded semaglutide?
regulatory action
No, and the reason is the whole point of this page. The approved schedule belongs to the approved product, and a compounded or research-grade vial has no approved label, so nothing in that schedule has been established as applying to what is inside it. The enforcement record shows why that is practical rather than legalistic. Compounded semaglutide turns up in FDA listings as Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, as Semaglutide, 5 mg/mL, pre-filled syringe, as Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, and as Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe.18202123 Those are four concentrations across four listings. An amount in milligrams therefore tells you nothing about the volume it comes in until you work out which concentration you are holding, and no source among the research behind this page ties a concentration to a seller.
What is the starting dose of compounded semaglutide?
regulatory action
There is no published answer, and the honest version of that is worth more than a number. No regulator has approved a compounded semaglutide vial, so no approved label states a starting amount for one. No trial among the research behind this page has given compounded semaglutide to anybody and reported what happened next. One enforcement record makes the difficulty concrete. In July 2025 a pharmacy recalled Semaglutide, 2.5 mg/mL injection, 0.8 mL, and the reason filed against it was Subpotent Drug, meaning the vial held less than its label said.22 So the milligrams printed on an unlabelled vial are a claim by whoever filled it, rather than a measurement anybody checked. An amount you cannot verify is not an amount you can follow.
How long did people stay on these amounts?
human RCT
Between 30 weeks and two years: the 2017 diabetes trial ran 30 weeks, the 2021 obesity trial ran 68 weeks, a 2024 trial in a predominantly east Asian population ran 44 weeks, and the 2025 higher-dose trial ran 72 weeks. The longest published exposure is two years. In that trial the mean change in body weight from baseline to week 104 was -15.2% in the semaglutide group (n = 152) versus -2.6% with placebo (n = 152), and 92.8% of whom completed the trial attended the end-of-trial safety visit.8 Nothing among the research behind this page follows anybody past 104 weeks of continuous weekly injection. No trial among the research behind this page has examined a break, a taper or a cycle either, so there is no interval to report rather than a short one. Two years is simply where the record stops, and a record stopping is not the same as nothing happening afterwards.
| Trial | Length |
|---|---|
| 2017 diabetes trial | 30 weeks |
| 2024 trial, predominantly east Asian population | 44 weeks |
| 2021 obesity trial | 68 weeks |
| 2025 higher-dose trial | 72 weeks |
| Two-year trial (152 per group) | 104 weeks |
Why do the published amounts vary?
human RCT
Because the trials were asking different questions of the same compound. The diabetes programme was built around blood sugar, and a 2021 head-to-head trial randomly assigned 1879 patients, in a 1:1:1:1 ratio, to receive tirzepatide at a dose of 5 mg, 10 mg, or 15 mg or semaglutide at a dose of 1 mg.4 The obesity programme settled on 2·4 mg and then looked either side of it. A 2025 comparison gave the maximum tolerated dose of semaglutide (1.7 mg or 2.4 mg) subcutaneously once weekly for 72 weeks, while a combination trial paired semaglutide at a dose of 2.4 mg and cagrilintide at a dose of 2.4 mg in one weekly injection.1415 So the range widens or narrows with the research question, rather than with anything about a particular person, and a number is worth no more than the question it answered.
What we don’t know
The gaps in the evidence matter as much as the findings.
- 01What is inside a compounded or research-grade vial. No analysis among the research behind this page reports the identity, concentration or sterility of semaglutide sold outside the approved supply.
- 02Whether the approved schedule means anything for an unlabelled vial. In the research behind this page, that comparison has not been made, and we will not make it here.
- 03What happens past 104 weeks. That is the longest published run of continuous weekly injection, and nothing among the research behind this page follows it.
- 04Whether a break, a taper or a cycle changes anything. No trial among the research behind this page has tested one, so there is no interval to report.
- 05Whether the injection site or the time of day matters. One trial fixed the area of the body and left the hour open, and no study among the research behind this page has compared either since.
- 06Whether body weight should change the amount. A 2024 systematic review found that body weight may affect exposure and said further study is needed.
- 07What anything below 0·5 mg once weekly does. That is the smallest injected arm on the published record, and nothing smaller has been assigned and measured.
- 08How an oral milligram figure lines up against an injected one. The two routes were measured separately, and no published comparison puts them on one scale.
Sources
- 1Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial Lancet Diabetes Endocrinol 2017. doi:10.1016/S2213-8587(17)30013-Xhuman RCT
- 2Once-Weekly Semaglutide in Adults with Overweight or Obesity N Engl J Med 2021. doi:10.1056/NEJMoa2032183human RCT
- 3Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial Lancet 2021. doi:10.1016/S0140-6736(21)00213-0human RCT
- 4Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes N Engl J Med 2021. doi:10.1056/NEJMoa2107519human RCT
- 5Safety of Semaglutide Front Endocrinol (Lausanne) 2021. doi:10.3389/fendo.2021.645563review
- 6Wegovy (semaglutide): a new weight loss drug for chronic weight management J Investig Med 2022. doi:10.1136/jim-2021-001952review
- 7Semaglutide for the treatment of obesity Trends Cardiovasc Med 2023. doi:10.1016/j.tcm.2021.12.008review
- 8Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial Nat Med 2022. doi:10.1038/s41591-022-02026-4human RCT
- 9Effects of oral semaglutide on cardiovascular outcomes in individuals with type 2 diabetes and established atherosclerotic cardiovascular disease and/or chronic kidney disease: Design and baseline characteristics of SOUL, a randomized trial Diabetes Obes Metab 2023. doi:10.1111/dom.15058human RCT
- 10Obesity Management in Adults: A Review JAMA 2023. doi:10.1001/jama.2023.19897review
- 11Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial Lancet Diabetes Endocrinol 2024. doi:10.1016/S2213-8587(23)00388-1human RCT
- 12Clinical Pharmacokinetics of Semaglutide: A Systematic Review Drug Des Devel Ther 2024. doi:10.2147/DDDT.S470826systematic review
- 13Real-world evidence on the utilization, clinical and comparative effectiveness, and adverse effects of newer GLP-1RA-based weight-loss therapies Diabetes Obes Metab 2025. doi:10.1111/dom.16364review
- 14Tirzepatide as Compared with Semaglutide for the Treatment of Obesity N Engl J Med 2025. doi:10.1056/NEJMoa2416394human pilot / early trial
- 15Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity N Engl J Med 2025. doi:10.1056/NEJMoa2502081human RCT
- 16Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity N Engl J Med 2025. doi:10.1056/NEJMoa2500969human RCT
- 17Once-weekly semaglutide 7·2 mg in adults with obesity (STEP UP): a randomised, controlled, phase 3b trial Lancet Diabetes Endocrinol 2025. doi:10.1016/S2213-8587(25)00226-8human RCT
- 18Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04 2025. sourceregulatory action
- 19Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 8438 2026. sourceregulatory action
- 20Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112 2025. sourceregulatory action
- 21Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirklan 2025. sourceregulatory action
- 22Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy 2025. sourceregulatory action
- 23Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. 2022. sourceregulatory action
- 24A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants NCT05784402registered trial
