The FDA-approved Saxenda is claimed to help weight loss when taken alongside a reduced-calorie diet and regular exercise. There are few clinical studies documenting its long-term effects as a weight-loss aid.
Below we have reviewed Saxenda against our review criteria to help consumers make an informed decision.
- FDA Advisory Committee positively reviewed and voted in favour of the product
- Nearly 5,000 people were used in clinical trials to evaluate its safety and efficiency
- Those given Saxenda in clinical trials usually lost more weight than those who weren’t, which suggests it is effective
- Its primary ingredient has been used in pharmacy for many years
- Only approved for people with a body mass index (BMI) of 30, or those with a BMI of 27, and if they suffer from a weight-related health problem
- It must be injected, which may not suit every user
- No follow-up studies have taken place yet
- A few rodent studies have shown it to cause thyroid tumours, although there’s no evidence to suggest this also occurs in humans
Saxenda copies the function of a natural human hormone first used to successfully treat type-2 diabetes. The Food and Drug Administration (FDA) approved Saxenda as an aid for weight management for obese or overweight people in December 2014, after evaluating the outcome of clinical tests. Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist, which means it causes a particular biological response when taken. The Saxenda supplement is very similar to the GLP-1 hormone in humans, which both decreases hunger and enhances the sense of feeling full. Its potential was only realised after type-2 diabetes patients using the drug reported weight loss. There are, however, no long-term studies of the drug as a weight management supplement, although these are scheduled to take place in time.
Claimed weight loss benefits
The chief weight management area that this product’s active ingredient, liraglutide, claims to focus on is appetite suppression. The product claims to help promote weight loss in the user solely by fabricating the feeling of being full. It should manipulate the user’s sense of hunger and in theory this should keep cravings and snacking at bay.
How Saxenda Works
The active ingredient in Saxenda is said to work by copying the naturally occurring GLP-1 hormone, which is created in the intestines. There are several functions of this hormone, including increasing insulin secretion and sensitivity, but it also helps weight control by slowing acid secretion and gastric emptying in the stomach. This is the rate by which food travels from the gut into the intestine. Saxenda works primarily to mimic another GLP-1 function of transmitting a message to your brain telling it you’ve eaten enough. Consequently, if Saxenda is indeed a successful supplement, it should quell the user’s hunger craving and so result in weight loss.
Liraglutide is the main component of Saxenda, designed to be taken once a day. It works largely to control blood sugar, but an injection of liraglutide, which will be the method of intake with Saxenda, is also claimed to slow the draining of the stomach. It firstly aids the pancreas by releasing the correct amount of insulin when a person’s blood sugar levels are high. Consequently, this then moves the sugar from the blood into the bodily tissue in order for it to be used for energy. Liraglutide reportedly functions as a form of appetite suppressant, as it slows the digestion of food from the stomach and signals a feeling of fullness to the brain.
Disodium Phosphate Dihydrate
Disodium phosphate dihydrate is one of the inactive ingredients in Saxenda. It’s also one of several sodium phosphates, which are used in a variety of food and medicinal products. Sodium phosphates act as a buffer in a solution in order to resist changes in its pH.
Propylene glycol works as a solvent in this product and is also often used by food, chemical and pharmaceutical sectors. It functions to absorb excess water with an aim of maintaining a certain level of moisture.
Phenol, sometimes known as carbolic acid, is another inactive ingredient of Saxenda that was also an ancestor of aspirin. It works as part of many other pharmaceutical products and is often used as an oral anaesthetic or analgesic.
Key Saxenda Ingredients
Saxenda is made up of just one active ingredient, liraglutide, and three other inert ingredients: phenol, propylene glycol and disodium phosphate dihydrate. Inert or inactive ingredients play no direct therapeutic part in the functioning of a drug and are instead used for processes such as binding, dyeing, flavouring or preserving. The focus of Saxenda is to inject a near-identical copy of a human hormone into the user so that the sense of satiety is replicated and the hunger pangs are suppressed. However, this was initially a medical drug administered in a smaller dose to treat sufferers of diabetes, so should be used with caution for a weight loss outcome.
Liraglutide, most commonly known under the name ‘Victoza’, is used in the medical world to control high blood sugar in patients with type-2 diabetes. It does this by increasing the amount of insulin, decreasing the volume of glucagon and slowing the exit of food from the stomach. A healthy diet and plenty of exercise is encouraged when taking liraglutide to help it work, which is also advised when taking Saxenda. High blood sugar can cause blindness, kidney damage, nerve problems and sexual function issues, as well as a heightened risk of strokes and heart attacks. Some users of liraglutide have suffered adverse reactions such as nausea, diarrhoea, vomiting and constipation.
Clinical trials are a respected way to prove or dispel the effectiveness of a weight loss product and the Saxenda supplement itself has been subject to three, approximately year-long studies, to test its mettle. These involved approximately 5,000 people with some participants receiving Saxenda and the rest, a placebo. This phase of the trial showed that 64% of those taking a 3 milligram (mg) daily-dose of the drug lost at least 5% of their weight, with 33% losing over 10% of their body mass. However, 27% of those taking the placebo also managed to shed at least 5% of their body weight, which may cast doubt over the success of Saxenda.
This trial involved analysing whether taking liraglutide could cause significant weight loss in obese people without diabetes. Obese or overweight participants who lost more than 5% of their body weight solely through dieting were randomly given either 3 mg of liraglutide or a placebo drug every day for 56 weeks, while continuing with diet and exercise. From starting on either liraglutide or a placebo, the average weight loss was measured at 6.2% for liraglutide takers and 0.2% for placebo users. The results of the study indicated that the participants taking liraglutide alongside dieting and exercising maintained the weight loss that was achieved by calorie-counting alone. It also suggested that liraglutide caused a higher weight loss than the placebo over the remaining 56 weeks, although there were some reports of digestive disorders from liraglutide participants.
Another study aimed to analyse the effects of liraglutide compared to a placebo drug. Randomised, controlled trials were examined to evaluate the outcome of using both liraglutide and a placebo to treat patients of type-2 diabetes. The results imply that, although liraglutide had greater hypoglycaemic, weight-loss and blood pressure-lowering qualities than its placebo counterpart, there were more negative side effects of using liraglutide that may balance the benefits of using it purely for weight-loss.
A 2011 study took place over one year and examined the efficiency and safety of liraglutide with that of sitagliptin in type-2 diabetes sufferers. There were two doses of liraglutide administered, a 1.2mg dose and a 1.8mg dose, and all drugs were combined with metaformin. The outcome indicated a 2.78kg and a 3.68kg weight loss with the 1.2mg and 1.8mg liraglutide doses respectively, whereas the sitagliptin results show only a 1.16kg decrease in weight. Despite a small number of users reporting nausea when taking liraglutide, the results show that it gave more lasting glycaemic control and weight loss over the course of the trial than sitagliptin, as well as a high satisfaction among its participants.
Saxenda Side Effects
The clinical trials that took place for Saxenda resulted in a list of reported side effects, despite this being a slight modification of a valued medicinal substance. The most commonly reported negative side effect of the drug was nausea, which was followed by similar ailments such as diarrhoea, dizziness, headaches, tiredness, vomiting, and low blood sugar. There isn’t any current evidence of any long-term effects, since it’s a new product on the market, but the growth of thyroid tumours in some rats during rodent testing may be a cause for concern.
Clinical trials conducted into the use of Saxenda’s only active ingredient liraglutide, both among diabetics and non-diabetics, are obviously very similar to those from studies into the product itself. Liraglutide side effects range from the mild to the very uncomfortable and include complaints such as nausea, diarrhoea, headache, indigestion, tiredness and back pain, although the exact number of reports regarding each ailment is unknown. Side effects similar to these may be more prevalent in Saxenda due to the high dose of liraglutide that constitutes it, although nausea and vomiting seem to be a repeated issue among participants of liraglutide trials.
Disodium Phosphate Dihydrate
As an inactive ingredient of Saxenda, it is highly unlikely to cause any negative side effects in the user. However, known adverse reactions to the phosphate salts family have been reported to include both bowel and digestive upsets, such as diarrhoea, constipation and stomach pains. There’s no evidence to prove this is affects a user of Saxenda.
Similarly, propylene glycol composes an extremely small part of Saxenda and so is not likely to cause any ailments. Reported side effects of propylene glycol elsewhere include respiratory and hypertension problems, but only if a large quantity is taken by adults. The solution has been used for more than half a century in the food, cosmetic and medical industries, although it has been known to cause lactic acidosis in certain users.
The use of phenol in Saxenda is also insignificant, but it is another inert ingredient that is evident in a host of other cosmetic and pharmaceutical products. Formerly known as carbolic acid, it is weakly acidic and may cause nausea, headaches, rashes or vomiting if taken in a large amount but these side effects are not based on well documented, scientific cases.
How to Use
There are a few important guidelines to know about Saxenda before choosing it as a weight loss plan. Users must inject Saxenda once every day, much like a diabetes patient would inject insulin. It is taken once daily and the dose is increased after one week until the user reaches the 3mg amount, although users can administer the supplement at any time of the day with or without food.
The design of dispensing and weight loss method of Saxenda means it is quite heavily reliant on observation by a healthcare professional and so users should certainly discuss with their doctor before taking it. Saxenda comes in a prefilled pen, but the user must be shown how to inject before using it alone and there are also the healthy diet and exercise regime to instate alongside the drug.
It’s also advised that pregnant women, nursing mothers or people who have families with a history of thyroid cancer do not take the drug and any signs of serious hypoglycemia, renal impairment, heart rate increase, allergic reactions or feelings of pain should be reported to a doctor immediately. This is strongly advised on the official Saxenda website.
Who Makes It?
Saxenda is a brand from globally-renowned Danish company Novo Nordisk, which was founded in 1923 and currently has production plants in seven separate countries. Novo Nordisk creates and markets products and services for the pharmaceutical agency and is a leader in diabetes care, haemophilia support, growth hormone treatment and hormone replacement therapy. Other drugs produced by Novo Nordisk include Levemir, NovoSeven and Victoza, all of which are created as part of a treatment plan for diabetes.
The company was launched by Nobel-winning scientist August Krogh, who started making insulin after being motivated by his wife’s battle with diabetes. The firm continues to focus on the study of diabetes, but ran into controversy in October 2013 when batches of insulin pens were recalled due to not meeting the requirements for insulin strength. This followed a breach of conduct in 2010 when Novo Nordisk didn’t reveal sufficient information regarding the side effects of its product Victoza.
Where to Buy Saxenda
Saxenda only received its FDA approval in December 2014 and is yet to be released on the market, although it will be made and distributed by Novo Nordisk. However, certain regulations surround the product that are sure to affect its accessibility. For example: it’s only approved for very overweight or obese people who have a minimum of one weight-connected condition. People using the drug should also be assessed 16 weeks after first taking Saxenda to evaluate its success and whether to continue. There’s also the implementation of the calorie-controlled diet and physical exercise regime to consider, so a healthcare professional will need to be heavily involved during the course of the Saxenda treatment. Consequently, obtaining Saxenda is unlikely to be as simple as ordering online like many other weight loss supplements.
Does Saxenda Meet our Approved Criteria
Money-back-guarantee: Not applicable as the product will be available via prescription.
One-off payment: Not applicable as the product will be available via prescription.
Manufacturing Standard: The product is FDA-approved.
Accompanying Diet Plan: The product should be taken alongside a diet plan and exercise regime that will be discussed with a healthcare progressional.
Ingredients and quantities disclosed: A full ingredients list is available.
Company contact details readily available: Full contact details are provided on the manufacturer’s website.
Saxenda does meet our ‘Approved’ criteria as it is an FDA-approved drug that should be available on prescription.
Clinical trials suggest that Saxenda does indeed work and can aid the user in losing weight steadily unlike many other quick-fix, but short-lived, supplements available. However, the user must also adopt a health-conscious lifestyle and the product will only be available to those who have made significant weight loss efforts in the past. There is a list of reported side effects certainly worth taking into account before opting for the drug, but Saxenda has not been shown to be dangerous in clinical trials to date.Google+
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