Saxenda® (liraglutide [rDNA origin] injection) Demonstrated Significant Improvements in Cardiometabolic Risk Factors Over Three Years Compared With Placebo

BOSTON, April 4, 2016 /PRNewswire/ -- Today, new data from the three-year part of the phase 3a SCALE™ (Satiety and Clinical Adiposity – Liraglutide Evidence) Obesity and Pre-diabetes trial were presented at the Endocrine Society's 98^th Annual Meeting and Expo (ENDO 2016). The three-year part of the trial (n=2,254 adults with obesity or who were overweight with comorbidities and had pre-diabetes at baseline) data demonstrated that 160 weeks of treatment with Saxenda^® (n=1,505) in combination with a reduced-calorie diet and increased physical activity resulted in significant improvements in cardiometabolic risk factors (such as blood pressure and cholesterol) compared with placebo (reduced-calorie diet and increased physical activity alone) (n=749).¹

At week 160, individuals treated with Saxenda^® had lost more weight (6.1%) than those treated with placebo (1.9%) (estimated treatment difference [ETD] -4.3% [95% CI, -4.9; -3.7], P<0.0001).¹ In addition, treatment with Saxenda^® achieved results beyond weight loss, including improvements in some cardiometabolic risk factors such as blood pressure and cholesterol. At week 160, participants randomized to treatment with Saxenda^® experienced a greater reduction in systolic blood pressure compared with placebo (ETD -2.8 mmHg [-3.8; -1.8], P<0.0001). Those treated with Saxenda^® also experienced greater improvements in triglycerides (ETD -6% [-9; -3], P=0.0003) and total cholesterol levels (ETD -2% [-3; 0], P=0.03) compared with placebo. Additionally, people treated with Saxenda^® showed a greater reduction in mean waist circumference (ETD -3.5 cm/-1.4 in [-4.2 cm/-1.7 in; -2.8 cm/-1.1 in]).

"We know that weight loss of as little as 5% to 10% in people with obesity can have an impact on cardiometabolic risk factors," said Dr. Ken Fujioka, Scripps Clinic, San Diego, California, and a SCALE™ clinical trial investigator. "This is currently the longest weight-management trial with Saxenda^® (liraglutide [rDNA origin] injection), and the observed improvements in blood pressure, lipids, and waist circumference at three years are encouraging."  

In addition, the three-year part of the SCALE™ Obesity and Pre-diabetes trial met its primary endpoint, demonstrating that continued treatment over three years with Saxenda^®, in combination with a reduced-calorie diet and increased physical activity, delayed the onset of type 2 diabetes compared with placebo.¹

Aligned with previous trials, during treatment with Saxenda^®, mean pulse rate was increased (ETD +2 beats/min [+1.2; +2.7], P<0.0001).¹ Saxenda^® was generally well tolerated, and observed side effects were in line with previous trials. Over 160 weeks, reports of serious adverse events were higher in those treated with Saxenda^® compared with placebo (15.1% vs 12.9%). Rates of gallbladder-related adverse events and confirmed acute pancreatitis were more frequent in those treated with Saxenda^® (2.9 events per 100 patient-years of observation [PYO] and 0.29/100 PYO, respectively) vs placebo (1.2/100 PYO and 0.13/100 PYO, respectively). The frequency of adjudicated major adverse cardiovascular events was low, and comparable in those treated with Saxenda^® and placebo (0.19 vs 0.20 events/100 PYO).¹ 

About SCALE™ Obesity and Pre-diabetes
SCALE™ is a randomized, double-blind, placebo-controlled, multinational trial in adults without diabetes who have obesity, and adults without diabetes who are overweight with weight-related comorbidities. There were 3,731 participants randomized to treatment with Saxenda^® or placebo in combination with a reduced-calorie diet and increased physical activity.² Participants were further stratified to 56 weeks or 160 weeks of treatment based on pre-diabetes status at baseline screening.³

The objectives of this trial were to demonstrate the safety and efficacy of Saxenda^® compared with placebo, as well as to investigate the long-term potential efficacy of Saxenda^® to delay the onset of type 2 diabetes in participants with pre-diabetes at baseline screening.³

It is the largest of the phase 3a trials in the SCALE™ clinical development program, which encompassed more than 5,000 adults with obesity or adults who are overweight with weight-related comorbidities.³

Indications and Usage

What is Saxenda^® (liraglutide [rDNA origin] injection)?
Saxenda^® is an injectable prescription medicine that may help some adults with excess weight (body mass index [BMI] ≥27) who also have weight-related medical problems or obesity (BMI ≥30), lose weight and keep the weight off. Saxenda^® should be used with a reduced-calorie meal plan and increased physical activity.

• Saxenda^® is not for the treatment of type 2 diabetes
• Saxenda^® and Victoza^® have the same active ingredient, liraglutide, and should not be used together
• Saxenda^® should not be used with other GLP-1 receptor agonist medicines
• Saxenda^® and insulin should not be used together
• It is not known if Saxenda^® is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products
• It is not known if Saxenda^® changes your risk of heart problems or stroke or of death due to heart problems or stroke
• It is not known if Saxenda^® can be used safely in people who have had pancreatitis
• It is not known if Saxenda^® is safe and effective in children under 18 years of age. Saxenda^® is not recommended for use in children

Important Safety Information

What is the most important information I should know about Saxenda^®?

Serious side effects may happen in people who take Saxenda^®, including:

1.    Possible thyroid tumors, including cancer. During the drug testing process, the medicine in Saxenda^® caused rats and mice to develop tumors of the thyroid gland. Some of these tumors were cancers. It is not known if Saxenda^® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid cancer in people. If medullary thyroid cancer occurs, it may lead to death if not detected and treated early. If you develop tumors or cancer of the thyroid, your thyroid may have to be surgically removed.

• Before you start taking Saxenda^®, tell your health care professional if you or any of your family members have had thyroid cancer, especially medullary thyroid cancer, or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not take Saxenda^® if you or any of your family members have medullary thyroid cancer, or if you have MEN 2. People with these conditions already have a higher chance of developing medullary thyroid cancer in general and should not take Saxenda^®
• While taking Saxenda^®, tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer

2.    Inflammation of the pancreas (pancreatitis), which may be severe and lead to death.

• Before taking Saxenda^® (liraglutide [rDNA origin] injection), tell your health care professional if you have had: pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. These medical conditions can make you more likely to get pancreatitis in general. It is not known if having these conditions will lead to a higher chance of getting pancreatitis while taking Saxenda^®
• While taking Saxenda^®: Stop taking Saxenda^® and call your health care professional right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may happen with or without vomiting. The pain may be felt going from your abdomen through to your back. This type of pain may be a symptom of pancreatitis

Who should not use Saxenda^®?

Do not use Saxenda^® if:

• you or any of your family members have a history of medullary thyroid cancer
• you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). This is a disease where people have tumors in more than one gland in their body
• you are allergic to liraglutide or any of the ingredients in Saxenda^®. Symptoms of a serious allergic reaction may include: swelling of your face, lips, tongue, or throat, fainting or feeling dizzy, very rapid heartbeat, problems breathing or swallowing, and severe rash or itching. Talk with your health care professional if you are not sure if you have any of these conditions
• are pregnant or planning to become pregnant. Saxenda^® may harm your unborn baby

What should I tell my health care professional before using Saxenda^®?

Before taking Saxenda^®, tell your health care professional if you:

• have any of the conditions listed in the section "What is the most important information I should know about Saxenda^®?"
• are taking certain medications called GLP-1 receptor agonists
• are allergic to liraglutide or any of the other ingredients in Saxenda^®
• have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food
• have or have had kidney or liver problems
• have or have had depression or suicidal thoughts
• have any other medical conditions
• are pregnant or plan to become pregnant. Saxenda^® (liraglutide [rDNA origin] injection) may harm your unborn baby. Tell your health care professional if you become pregnant while taking Saxenda^® If you are pregnant you should stop using Saxenda^®
• are breastfeeding or plan to breastfeed. It is not known if Saxenda^® passes into your breast milk. You and your health care professional should decide if you will take Saxenda^® or breastfeed. You should not do both without talking with your health care professional first

Tell your health care professional about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Saxenda^® slows stomach emptying and can affect medicines that need to pass through the stomach quickly. Saxenda^® may affect the way some medicines work and some other medicines may affect the way Saxenda^® works. Tell your health care professional if you take diabetes medicines, especially sulfonylurea medicines or insulin.

Know the medicines you take. Keep a list of them with you to show your health care professional and pharmacist each time you get a new medicine.

How should I use Saxenda^®?

• Inject your dose of Saxenda^® under the skin (subcutaneous injection) in your stomach area (abdomen), upper leg (thigh), or upper arm, as instructed by your health care professional. Do not inject into a vein or muscle
• Never share your Saxenda^® pen or needles with another person. You may give an infection to them, or get an infection from them

What are the possible side effects of Saxenda^®?

Saxenda^® may cause serious side effects, including:

• possible thyroid tumors, including cancer
• inflammation of the pancreas (pancreatitis)
• gallbladder problems. Saxenda^® may cause gallbladder problems including gallstones. Some gallbladder problems need surgery. Call your health care professional if you have any of the following symptoms: pain in your upper stomach (abdomen), fever, yellowing of your skin or eyes (jaundice), and clay-colored stools
• low blood sugar (hypoglycemia) in people with type 2 diabetes who also take medicines to treat type 2 diabetes. Saxenda^® can cause low blood sugar in people with type 2 diabetes who also take medicines used to treat type 2 diabetes (such as sulfonylureas). In some people, the blood sugar may get so low that they need another person to help them. If you take a sulfonylurea medicine, the dose may need to be lowered while you use Saxenda^® (liraglutide [rDNA origin] injection). Signs and symptoms of low blood sugar may include: shakiness, sweating, headache, drowsiness, weakness, confusion, irritability, hunger, fast heartbeat, feeling jittery, and dizziness. You should check your blood sugar before you start taking Saxenda^® and while you take Saxenda^®
• increased heart rate. Saxenda^® can increase your heart rate while you are at rest. Your health care professional should check your heart rate while you take Saxenda^®. Tell your health care professional if you feel your heart racing or pounding in your chest and it lasts for several minutes when taking Saxenda^®
• kidney problems (kidney failure). Saxenda^® may cause nausea, vomiting, or diarrhea leading to loss of fluids (dehydration). Dehydration may cause kidney failure, which can lead to the need for dialysis. This can happen in people who have never had kidney problems before. Drinking plenty of fluids may reduce your chance of dehydration. Call your health care professional right away if you have nausea, vomiting, or diarrhea that does not go away, or if you cannot drink liquids by mouth
• serious allergic reactions. Serious allergic reactions can happen with Saxenda^®. Stop using Saxenda^®, and get medical help right away if you have any symptoms of a serious allergic reaction
• depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your health care professional right away if you have any mental changes that are new, worse, or worry you

Common side effects of Saxenda^® include nausea, diarrhea, constipation, low blood sugar (hypoglycemia), vomiting, headache, decreased appetite, upset stomach, tiredness, dizziness, stomach pain, and changes in enzyme (lipase) levels in your blood. Nausea is most common when first starting Saxenda^®, but decreases over time in most people as their body gets used to the medicine. Tell your health care professional if you have any side effect that bothers you or that does not go away.

Please click here for Prescribing Information.

About Saxenda^®

Saxenda^® is a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, Saxenda^® regulates appetite and lowers body weight through decreased food intake. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and reduces glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of blood glucose. Saxenda^® was evaluated in the SCALE™ (Satiety and Clinical Adiposity−Liraglutide Evidence in Non-diabetic and Diabetic adults) phase 3 clinical trial program.²

Saxenda^® (liraglutide [rDNA origin] injection) was approved by the FDA on December 23, 2014, as an adjunct to a reduced- calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI of ≥30 kg/m²) or who are overweight (BMI of ≥27 kg/m²) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).^2,3

As of February 2016, Saxenda^® injection has been commercially launched in the United States, Canada, and Denmark. It has also been approved in the European Union, Mexico, and Australia. Please refer to local labels for more information.

About obesity 

The global increase in the prevalence of obesity is a public health issue that has severe cost implications to health care systems.^4,5 In 2011–2012 in the United States, approximately 35% of adults, or nearly 79 million adults, lived with obesity.^6,7 

Guidance is given in all labels that treatment with Saxenda^® should be discontinued if a specific threshold of weight loss has not been achieved after a certain period of time.

About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people with other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has more than 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

Please see Important Safety Information throughout.

References

1. Fujioka K, Greenway F, Krempf M, et al. Liraglutide 3.0 mg reduces body weight and improves cardiometabolic risk factors in adults with obesity or overweight and prediabetes: the SCALE Obesity and Prediabetes randomized, double-blind, placebo-controlled 3-year trial. Poster presented at: The 97^th Annual Meeting of the Endocrine Society. April 1-4, 2016; Boston, MA.
2. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015. 
3. Data on file. Novo Nordisk Inc; Plainsboro, NJ.
4. World Health Organization. Fact sheet no. 311: obesity and overweight. http://www.who.int/mediacentre/factsheets/fs311/en/. Updated January 2015. Accessed August 11, 2015.
5. Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Economics. 2012;31(1):219-230.
6. Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014;311(8):806-814.
7. Centers for Disease Control and Prevention. Adult obesity facts. http://www.cdc.gov/obesity/data/adult.html. Updated September 21, 2015. Accessed October 26, 2015.

Saxenda^® and Victoza^® are registered trademarks and SCALE^TM is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2016 Novo Nordisk   All rights reserved.   USA16SAM00693   April 2016

SOURCE Novo Nordisk Inc.

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