Protocols
Liraglutide protocols in the published literature
StatusFDA approved
PeptideHound Staff · Last editorially reviewed · 18 sources
Liraglutide trials used three amounts, all given once a day by injection under the skin: 1·2 mg and 1·8 mg for blood sugar, and 3·0 mg for weight. The weight amount is the one behind the Saxenda approval, and each of those figures came from a pen of known strength rather than from a vial.
The 3·0 mg trials are the deep end of the record. They ran from 26 to 56 weeks, in adults on insulin, adults without diabetes and adults at high heart risk, and one of them followed people for a further year after the injections stopped.
A 2019 development history records that weight loss led to the approval of liraglutide at 3·0 mg for obesity, which makes that figure a regulatory fact rather than our view of what anyone should take. The step-up schedule printed on the label is not among the sources behind this page, so this page does not print one.
The pens hold 18 mg in 3 mL. That arithmetic, and every amount above, belongs to the approved product. A compounded or research-grade vial has no label, no stated strength anyone has checked, and no trial behind it.
Evidence: Not dosing guidance · the approved weight amount is 3.0 mg once daily · trial amounts of 1.2, 1.8 and 3.0 mg reported as trial parameters · the label's step-up schedule is not reproduced here · compounded and research-grade vials carry no approved label
What amounts of liraglutide did the published trials use?
human RCT
Three amounts carry the whole record, and each one belongs to a different question. The lowest is 1·2 mg a day. A 30-week diabetes trial chose it because it was the current most frequently prescribed liraglutide dose in Europe, and set it against weekly semaglutide.1 The middle amount is 1·8 mg a day. A 48-week phase 2 trial in people with fatty liver inflammation gave subcutaneous injections of liraglutide at 1·8 mg daily against placebo.2 The top amount is 3·0 mg a day, and it runs through every weight trial covered here. The SCALE Insulin trial randomised 198 people to liraglutide 3·0 mg and 198 to placebo for 56 weeks.3 A Copenhagen trial gave liraglutide (3·0 mg per day) for a year, and a Texas trial gave the same amount for 40 weeks with MRI scans of belly fat.45 Read those as three separate experiments rather than three rungs of one ladder. None of the trials covered here compared two liraglutide amounts against each other, so the record tells you what each amount did in its own population and not what moving between them does.
| Trial | Daily amount | Compared with | Length |
|---|---|---|---|
| Diabetes trial | 1·2 mg | Weekly semaglutide | 30 weeks |
| Phase 2 trial, fatty liver inflammation | 1·8 mg | Placebo | 48 weeks |
| SCALE Insulin, 198 per arm | 3·0 mg | Placebo | 56 weeks |
| Copenhagen trial | 3·0 mg | Not stated here | A year |
| Texas trial, MRI of belly fat | 3·0 mg | Not stated here | 40 weeks |
What does the approved liraglutide label cover?
review
The weight approval is tied to one figure. A 2019 development history records that significant weight loss, through an effect to reduce energy intake, led to the approval of liraglutide at 3·0 mg for obesity.6 The diabetes approval came first, and a 2011 review calls liraglutide the first once-daily human GLP-1 analogue developed for type 2 diabetes.7 A 2023 JAMA review lists liraglutide among six medications currently approved by the US Food and Drug Administration for long-term use in obesity.8 We report those because they are regulatory facts, in the same way a page would report that a compound is approved for nothing. They are not a view of ours about what anyone should take. The label also prints a step-up schedule for the first weeks. That schedule is not in the research behind this page, so it is not reproduced here, and a reader who wants it will find it on the leaflet in the carton rather than in a summary that could drift from it.
How was liraglutide given, and how often?
systematic review
Once a day, under the skin, every time. A 2011 review gives the reason, describing a half-life after injection that makes it suitable for once-daily dosing.7 A half-life is the time it takes for half of an injected amount to clear the blood. At least one trial put the injection in the participants' own hands, describing subcutaneous self-injections of once-daily liraglutide 3·0 mg as its active comparison arm.9 One slip in the published record is worth knowing about. A 2025 pooled analysis describes liraglutide at 3·0 mg weekly or 1·8 mg daily, although every 3·0 mg trial behind this page that states its interval gave it once a day.10 That is almost certainly a wording error in one summary rather than a weekly regimen anyone tested, and it shows how easily a schedule changes as it is copied from paper to paper. A weekly 3·0 mg injection of liraglutide does not appear in any trial covered here, which makes it a different exposure rather than a variant of the studied one.
What was the starting amount in the liraglutide trials?
human RCT
The abstracts behind this page report the amount each arm reached rather than the amount it began at, and that is worth being plain about before reading anything else into them. The trial in young people with type 2 diabetes is the clearest sign that a climb happened at all, because it describes liraglutide given at up to 1·8 mg per day rather than at a single fixed figure.11 The dose-finding trial that used liraglutide as a comparator describes a 26-week treatment period, including a dose-escalation period of up to 6 weeks, which is the run of weeks spent stepping upward before the assigned amount is held.9 That escalation window covers every active arm in that trial rather than liraglutide alone, so it says nothing precise about the liraglutide steps. The honest summary is that the trials climbed to their amounts and the abstracts do not print the rungs. The label does, and it is the document that holds them.
How many doses does an 18 mg liraglutide pen hold?
regulatory action
The pens on the recall register state their strength, describing Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), in a single 3 mL prefilled pen.12 The Victoza pen listed on the same day carries the same 18 mg/3 mL (6 mg/mL) strength.13 From there it is division. Eighteen milligrams holds six amounts of 3·0 mg, ten of 1·8 mg, or fifteen of 1·2 mg. At 6 mg in every millilitre, 3·0 mg is half a millilitre of liquid, 1·8 mg is 0·3 mL and 1·2 mg is 0·2 mL. Those figures are arithmetic on a printed strength rather than anything a study measured, and the pen's own leaflet governs how it is actually used. They also hold only at 6 mg/mL. A vial at any other strength changes every number in this section, and the arithmetic for a powder that has to be mixed is worked through on the reconstitution calculator, which takes your numbers and suggests none of its own.
What amounts of liraglutide were used in children?
human RCT
Two trials went below adult age. In the first, patients who were 10 to less than 17 years of age were randomly assigned to subcutaneous liraglutide at up to 1·8 mg per day or to placebo.11 Those children all had type 2 diabetes, and all the patients received metformin during the trial, so the amount was given alongside another medicine rather than on its own.11 The second trial went younger, to children aged 6 to under 12 with obesity, and ran a 56-week treatment period followed by a 26-week follow-up period.14 Its abstract reports the result but not the amount the children received, so this page does not supply one. Filling that blank with the adult weight figure would be a guess presented as a fact, and an amount for a six-year-old is the last place a guess belongs.
How much liraglutide is in Xultophy?
registered trial
Xultophy puts liraglutide in the same pen as a long-acting insulin, and its listing gives both strengths as 100 units/mL and 3·6 mg/mL.15 Because the two sit in one liquid at a fixed ratio, the amount of liraglutide a person receives from that pen is set by the insulin units dialled rather than chosen separately. Every 10 units of insulin carry 0·36 mg of liraglutide, by simple division on the label strengths. How fast to climb on that combined pen was itself the subject of a completed trial, which compared insulin degludec and liraglutide in people with type 2 diabetes using two different titration algorithms.16 Titration means stepping an amount up or down by a rule. The point for anyone comparing figures is that a Xultophy amount and a Saxenda amount are not the same kind of number, since one rides on insulin units and the other is measured in milligrams of liraglutide alone.
How much weight can you lose on Saxenda in 3 months?
human RCT
No trial among these sources reports a weight figure at three months on 3·0 mg, and the one that comes closest shows why an early number is easy to misread. The Copenhagen trial put everyone on an 8-week low-calorie diet before any injection, and after that diet, 195 participants had a mean decrease in body weight of 13·1 kg.4 Only then did the injections begin, and at one year the liraglutide group had lost 6·8 kg more than the placebo group.4 Read that sequence carefully. The large early drop in that trial came from the diet, before liraglutide was given, and the injection's job was to hold and extend it over the following year. So a three-month figure quoted for Saxenda is either arithmetic done on a later average or a number from a programme that bundled a diet with the pen. Neither is a measurement of what three months of liraglutide does, and the trial endpoints themselves are set out on the main the Liraglutide overview page.
Is there a cycle or a break in the liraglutide research?
human RCT
Among these sources, no trial put an on-and-off pattern to the test. Every arm ran continuously to its endpoint and then stopped, which makes the one stop that was followed up the closest thing to a break in the record. That follow-up came from Copenhagen, where weight regain in the year after stopping was 6·0 kg larger after termination of liraglutide compared with after termination of supervised exercise.17 The authors summed it up as body weight maintained one year after supervised exercise ended, in contrast to weight regain after termination of treatment with obesity pharmacotherapy alone.17 A 2025 real-world review lists studies of the effects of stopping GLP-1RA treatment among the areas still needing research.18 So stopping has been measured once, as a full stop after a year, and a cycle has not been measured at all. Those are different questions, and the first answer does not tell you anything about the second.
Does the approved amount apply to compounded or research-grade liraglutide?
review
No, and the reason is a matter of what the figure is attached to rather than a matter of chemistry. Every amount on this page was given from a pen made to a filed strength, and the recall register shows how much that strength depends on handling. Sample pens stored below 32°F were pulled because the cold could cause a lack of efficacy and damage to the cartridge.12 A pen kept too cold can stop delivering what its label says, and that pen at least has a label to fall short of. A compounded or research-grade vial has no approved strength, no batch on the register and no trial behind it. The approval itself names a molecule at an amount for a use, recorded as liraglutide at 3·0 mg for obesity, and it does not travel to a container nobody licensed.6 So 3·0 mg on a vial is a number, while 3·0 mg in a Saxenda pen is a number with a specification and a regulator behind it. They are different things that happen to share a figure.
Why do the published liraglutide amounts vary?
human RCT
Because each trial chose its amount to answer its own question, and the choice is usually stated. The diabetes comparison picked 1·2 mg to mirror practice, comparing the anticipated most frequent semaglutide dose with the most often prescribed liraglutide dose, reflecting clinical practice.1 The liver trial picked 1·8 mg, the higher of the two diabetes amounts in these trials, and the weight trials took the amount that carried the obesity approval.2 Outside trials the picture shifts again, since a 2025 review of real-world use reports the use of much lower doses than those evaluated in clinical trials across this class.18 That last finding describes what people did rather than what anyone tested. A lower amount taken in ordinary life is a different exposure from every published arm, and whether it does anything at that size is a question none of these trials was designed to ask.
What we don’t know
The gaps in the evidence matter as much as the findings.
- 01The label's step-up schedule. It is printed on every pen leaflet, and it is not reproduced in the research behind this page, so we report the trial amounts and leave the schedule to the label itself.
- 02What amount the children aged six to under twelve received. The trial abstract reports the result and not the amount, and we will not fill the gap with the adult figure.
- 03Whether taking breaks changes anything. No trial among the research behind this page tested an on-and-off pattern, so there is no interval to report.
- 04How much weight comes off in the first month or three. The earliest endpoint covered here is week 26, and the one trial with an early figure attributes it to a diet that came before the injection.
- 05What strength a compounded or research-grade vial actually holds. No analysis among the research behind this page has measured one, so the pen arithmetic below cannot be assumed to carry over.
Sources
- 1Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10) Diabetes Metab 2020. doi:10.1016/j.diabet.2019.101117human RCT
- 2Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study Lancet 2016. doi:10.1016/S0140-6736(15)00803-Xhuman RCT
- 3Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial Diabetes Care 2020. doi:10.2337/dc19-1745human RCT
- 4Healthy Weight Loss Maintenance with Exercise, Liraglutide, or Both Combined N Engl J Med 2021. doi:10.1056/NEJMoa2028198human RCT
- 5Effects of liraglutide on visceral and ectopic fat in adults with overweight and obesity at high cardiovascular risk: a randomised, double-blind, placebo-controlled, clinical trial Lancet Diabetes Endocrinol 2021. doi:10.1016/S2213-8587(21)00179-0human RCT
- 6The Discovery and Development of Liraglutide and Semaglutide Front Endocrinol (Lausanne) 2019. doi:10.3389/fendo.2019.00155review
- 7[Liraglutide] Nihon Rinsho 2011. PMID 21595276review
- 8Obesity Management in Adults: A Review JAMA 2023. doi:10.1001/jama.2023.19897review
- 9Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial Lancet 2021. doi:10.1016/S0140-6736(21)01751-7human RCT
- 10Effect of glucagon-like peptide-1 receptor agonists and co-agonists on body composition: Systematic review and network meta-analysis Metabolism 2025. doi:10.1016/j.metabol.2024.156113systematic review
- 11Liraglutide in Children and Adolescents with Type 2 Diabetes N Engl J Med 2019. doi:10.1056/NEJMoa1903822human RCT
- 12Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, 2021. sourceregulatory action
- 13ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-406 2021. sourceregulatory action
- 14Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial N Engl J Med 2025. doi:10.1056/NEJMoa2407379human RCT
- 15Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: N 2021. sourceregulatory action
- 16A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms NCT02298192registered trial
- 17Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial EClinicalMedicine 2024. doi:10.1016/j.eclinm.2024.102475human RCT
- 18Real-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
