Saxenda: Complete Guide to Liraglutide 3 mg for Weight Loss
At a glance
- Drug / Saxenda (liraglutide 3 mg)
- Class / GLP-1 receptor agonist
- How it is taken / Subcutaneous injection once daily, any time of day, with or without meals [1]
- Maintenance dose / 3 mg daily from week 5; lower doses are for titration only [1]
- Approved for / Weight management with diet and activity: adults with obesity, adults with overweight plus a weight-related condition, and patients aged 12 and older above 60 kg with obesity [1]
- 56-week result / -7.4% body weight versus -3.0% with placebo [1]
- Most common side effect / Nausea, 39.3% versus 13.8% on placebo [1]
- Boxed warning / Thyroid C-cell tumors in rodents; contraindicated with a personal or family history of MTC or MEN 2 [1]
What Saxenda is and how it works
Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous GLP-1(7-37). It is stable against DPP-4 and neutral endopeptidase degradation, and its plasma half-life after subcutaneous injection is about 13 hours, against 1.5 to 2 minutes for native GLP-1 [1].
The label describes GLP-1 as a physiological regulator of appetite and calorie intake, notes that GLP-1 receptors are present in brain areas involved in appetite regulation, and states that liraglutide delays gastric emptying [1]. The label gives a peak concentration at about 11 hours, absolute bioavailability about 55% and more than 98% protein binding [1].
Victoza is the liraglutide product labeled for type 2 diabetes, while Saxenda is labeled for chronic weight management at a recommended dose of 3 mg daily. The label says not to combine Saxenda with Victoza or with any other GLP-1 receptor agonist [1].
Who the label covers
The indication is weight management, in combination with a reduced-calorie diet and increased physical activity, for adults with obesity and for adults with overweight plus at least one weight-related comorbid condition such as hypertension, type 2 diabetes or dyslipidemia [1].
It also covers patients aged 12 years and older with body weight above 60 kg and obesity. In adolescents, the label defines obesity as a BMI corresponding to 30 kg/m² or greater for adults by international cut-offs [1]. The safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes have not been established [1].
Dosing: 0.6 mg to 3 mg in five weeks
| Week | Daily dose |
|---|---|
| 1 | 0.6 mg |
| 2 | 1.2 mg |
| 3 | 1.8 mg |
| 4 | 2.4 mg |
| 5 and onward | 3 mg |
The label starts treatment at 0.6 mg daily for one week and raises the dose weekly, explicitly to reduce the risk of gastrointestinal adverse reactions [1]. For adults, 3 mg daily is the recommended dose, lower doses are for titration only, and the label says to discontinue Saxenda if the 3 mg dose cannot be tolerated; if a step up is not tolerated, escalation may be delayed about one week [1].
The prescribing information describes Saxenda as a once-daily subcutaneous injection into the abdomen, thigh or upper arm, taken at any time of day without regard to meals. It also describes resuming the next scheduled dose after a missed dose and restarting titration at 0.6 mg if more than 3 days have passed. For adolescents, escalation may take up to 8 weeks, and a patient who does not tolerate 3 mg may be reduced to 2.4 mg daily [1].
The label sets a 16-week checkpoint: evaluate weight change 16 weeks after starting, and discontinue if the patient has not lost at least 4% of baseline body weight, because clinically meaningful weight loss with continued treatment is unlikely [1].
How much weight loss the trials showed
The label's Study 1, SCALE Obesity and Prediabetes, enrolled 3,731 adults without type 2 diabetes who had a BMI of 30 or higher, or 27 or higher with dyslipidemia or hypertension; 2,487 received liraglutide 3.0 mg and 1,244 placebo, all with lifestyle counseling, for 56 weeks [2]. The published report gives a mean loss of 8.4 kg versus 2.8 kg, with 63.2% versus 27.1% losing at least 5% of body weight and 33.1% versus 10.6% losing more than 10% [2]. The label reports the same trial as a mean change of -7.4% versus -3.0%, with 62.3% versus 34.4% losing at least 5% and 33.9% versus 15.4% losing more than 10% [1].
Weight loss is smaller in people who have type 2 diabetes. In the 56-week SCALE Diabetes trial, 846 adults with overweight or obesity and type 2 diabetes received liraglutide 3.0 mg (n=423), 1.8 mg (n=211) or placebo (n=212) [6]. Weight loss was 6.0% with liraglutide 3.0 mg, 4.7% with 1.8 mg and 2.0% with placebo, with at least 5% lost by 54.3%, 40.4% and 21.4% respectively [6].
A third trial tested maintenance. Four hundred twenty-two adults who had already lost at least 5% of body weight on a low-calorie diet were randomized to liraglutide 3 mg or placebo for 56 weeks; those adults lost an additional mean 6.2% with liraglutide versus 0.2% with placebo, and 50.5% versus 21.8% lost at least 5% of their randomization weight [7].
How Saxenda compares with the weekly options
Semaglutide 2.4 mg once weekly was tested in 1,961 adults with obesity or overweight and no diabetes over 68 weeks: mean weight change -14.9% versus -2.4% with placebo, with 86.4% versus 31.5% losing at least 5% [4]. Tirzepatide, a dual GIP and GLP-1 receptor agonist, was tested in 2,539 adults over 72 weeks: -15.0% at 5 mg, -19.5% at 10 mg and -20.9% at 15 mg weekly versus -3.1% with placebo [5].
Each of those figures comes from a separate trial with its own population, dose schedule and analysis, so they are not a direct comparison against Saxenda's numbers.
Cardiovascular outcomes
The liraglutide cardiovascular outcomes trial, LEADER, tested Victoza (1.8 mg target dose), not Saxenda. In 9,340 adults with type 2 diabetes and high cardiovascular risk, cardiovascular death, nonfatal heart attack or nonfatal stroke occurred in 13.0% of participants receiving liraglutide and 14.9% receiving placebo over a median 3.8 years [8]. Saxenda's approved indication is weight management, not cardiovascular risk reduction [1].
Side effects and label warnings
Safety in adults comes from five placebo-controlled trials: 3,384 people on Saxenda and 1,941 on placebo, for up to 56 weeks at 3 mg daily [1]. Nausea occurred in 39.3% versus 13.8%, diarrhea in 20.9% versus 9.9%, constipation in 19.4% versus 8.5%, vomiting in 15.7% versus 3.9%, injection-site reactions in 13.9% versus 10.5%, headache in 13.6% versus 12.6%, dyspepsia in 9.6% versus 2.7% and increased lipase in 5.3% versus 2.2% [1]. About 68% versus 39% reported any gastrointestinal disorder, and nausea declined as treatment continued [1]. Adverse reactions led 9.8% versus 4.3% to stop treatment, most often nausea (2.9% versus 0.2%) [1]. Hair loss appears in the label's postmarketing skin reactions with frequency not established, not in the trial tables [1].
- Boxed warning. Liraglutide caused dose- and duration-dependent thyroid C-cell tumors in rats and mice at clinically relevant exposures; whether it causes them in humans is unknown. Saxenda is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2, and the label states that routine calcitonin or thyroid ultrasound monitoring is of uncertain value [1].
- Pancreatitis. The label says to discontinue Saxenda if pancreatitis is suspected [1].
- Gallbladder disease. Cholelithiasis was reported in 2.2% versus 0.8% and cholecystitis in 0.8% versus 0.4%, and the label notes the excess persisted after accounting for the degree of weight loss [1].
- Heart rate. Mean resting heart rate rose 2 to 3 bpm, and 34% versus 19% had rises of more than 10 bpm at two consecutive visits; the label says to monitor heart rate at regular intervals [1].
- Kidney injury. Acute kidney injury from volume depletion is labeled, with monitoring of renal function in patients with reactions that could cause volume depletion [1].
- Hypersensitivity and aspiration. Anaphylaxis and angioedema are reported postmarketing, and pulmonary aspiration has been reported during general anesthesia or deep sedation; the label lists these [1].
- Hypoglycemia. Among adults with type 2 diabetes taking a sulfonylurea, glucose below 54 mg/dL occurred in 28.2% versus 12.7% (sulfonylurea doses were cut 50% at the start); the label advises reducing the insulin or secretagogue dose [1]. In adolescents without diabetes, symptomatic hypoglycemia below 70 mg/dL occurred in 15.2% versus 4% [1].
The suicidal-thoughts warning was removed in 2026
On January 13, 2026, FDA said it had reviewed a meta-analysis of 91 placebo-controlled GLP-1 receptor agonist trials (107,910 patients, 60,338 on a GLP-1 drug) plus a claims cohort of 2,243,138 new users and published studies, found no increased risk of suicidal ideation or behavior, and asked the makers of Saxenda, Wegovy and Zepbound to remove that language from their labels [10]. The Saxenda label effective February 25, 2026 no longer contains a suicidal behavior and ideation section; the version dated January 26, 2024 carried one titled 'Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts' [1][11]. Depression still appears in the pediatric trial table at 4% versus 2.4% [1].
Pregnancy and birth control pills
The current Saxenda label's contraindications are a personal or family history of medullary thyroid carcinoma or MEN 2, and serious hypersensitivity to liraglutide or an excipient [1]. Pregnancy is not listed as a contraindication: the risk summary says to use Saxenda during pregnancy only if the potential benefit justifies the potential risk to the fetus, that weight loss offers no benefit in pregnancy, and that Saxenda should be discontinued when pregnancy is recognized [1]. The January 2024 version did list pregnancy as a contraindication [11].
On oral contraceptives, a study with 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel found liraglutide lowered the peak concentration of ethinylestradiol by 12% and of levonorgestrel by 13%, left ethinylestradiol exposure (AUC) unchanged, raised levonorgestrel AUC by 18% and delayed time to peak by 1.5 hours; the Saxenda label gives no instruction to switch or add a barrier method [1].
Saxenda in adolescents
The 56-week trial enrolled 251 adolescents aged 12 to under 18 with obesity: 125 on liraglutide 3.0 mg and 126 on placebo, both with lifestyle therapy [12]. The BMI standard-deviation score fell by an estimated 0.22 more with liraglutide than placebo (95% CI -0.37 to -0.08; P=0.002) [12]. A BMI reduction of at least 5% occurred in 43.3% versus 18.7%, and of at least 10% in 26.1% versus 8.1% [12]. Gastrointestinal adverse events occurred in 64.8% versus 36.5%, and 10.4% versus 0% stopped treatment because of adverse events [12]. The label's pediatric table shows nausea 42.4% versus 14.3%, vomiting 34.4% versus 4%, diarrhea 22.4% versus 14.3% and depression 4% versus 2.4% [1]. One death by suicide occurred in the liraglutide group and was judged by the investigator as unlikely related to treatment [12].
Stopping Saxenda
The indication itself is to reduce excess body weight and maintain weight reduction long term [1]. In the adolescent trial, weight regain after treatment stopped was greater with liraglutide than with placebo during the 26-week follow-up [12].
Generics and compounded liraglutide
FDA-approved generic liraglutide exists. Generics referencing Saxenda carry labels from Teva (ANDA 214568), Biocon (ANDA 217063) and Cipla (ANDAS 217234), among others [13]. On April 30, 2026, FDA proposed to exclude semaglutide, tirzepatide and liraglutide from the list of bulk substances that outsourcing facilities may compound with, finding no clinical need, with comments due June 29, 2026 and no final decision found [14]. Compounded drugs are not FDA approved and are not reviewed for safety, effectiveness or quality [15].
Frequently asked questions
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References
- U.S. National Library of Medicine, DailyMed. Saxenda injection (liraglutide) prescribing information. Saxenda injection (liraglutide) label
- Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, et al. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015;373(1):11-22. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management
- Gleason PP, Urick BY, Marshall LZ, Friedlander N, Qiu Y, Leslie RS. Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes. J Manag Care Spec Pharm. 2024;30(8):860-867. Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, et al. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021;384(11):989-1002. Once-Weekly Semaglutide in Adults with Overweight or Obesity
- Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022;387(3):205-216. Tirzepatide Once Weekly for the Treatment of Obesity
- Davies MJ, Bergenstal R, Bode B, Kushner RF, Lewin A, Skjøth TV, et al. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA. 2015;314(7):687-99. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial
- Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, et al. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013;37(11):1443-51. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study
- Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016;375(4):311-22. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes
- Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. N Engl J Med. 2023;389(24):2221-2232. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes
- FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications | FDA. FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications | FDA
- U.S. National Library of Medicine, DailyMed. Saxenda injection (older repackager version, used only for the pre-2026 suicidality wording) (liraglutide) prescribing information. Saxenda injection (older repackager version, used only for the pre-2026 suicidality wording) (liraglutide) label
- Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, et al. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020;382(22):2117-2128. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on Bulks List | FDA. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on Bulks List | FDA
- FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | FDA. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss | FDA