Benzinga | Nov 5, 2021 09:44AM EDT

Novo Nordisk; Highlights Presentation Of Results From STEP 5 Phase 3b Trial; Says Wegovy 'demonstrated significant and sustained weight loss' In Two-Year Study

Results from the STEP 5 phase 3b trial, presented today at the ObesityWeek(r) 2021 interactive congress, showed that adults treated with Wegovy(tm) (semaglutide) injection 2.4 mg achieved significant and sustained weight loss over the two-year study period.1 The STEP 5 trial investigated Wegovy(tm) vs. placebo, both used with a reduced calorie meal plan and increased physical activity, for the treatment of obesity (BMI ?30 kg/m2) or overweight (BMI ?27 kg/m2) in 304 adults for 104 weeks (two years).1

In the STEP 5 trial, results showed that Wegovy(tm) significantly reduced body weight from baseline to week 104 compared to placebo (-15.2% vs. -2.6%, estimated treatment difference: -12.6% points [95% CI: -15.3, -9.8]; p<0.0001). The study also demonstrated that adults with overweight or obesity were more likely to lose at least 5% of their body weight with Wegovy(tm) vs. placebo (77.1% vs. 34.4%; p<0.0001).1

"People with obesity try on average seven times to lose weight before seeking medical care. Once weight is lost, however, it all too often comes back, which is why it is critically important to find options to help people living with obesity lose weight and keep it off," said W. Timothy Garvey, MD, Professor of Medicine, Department of Nutrition Sciences at the University of Alabama in Birmingham. "Results from the STEP 5 clinical trial demonstrated that adults with obesity were able to lose weight while taking Wegovy(tm) and maintain the weight loss at two years, which can help us better treat and manage obesity as a chronic disease."

Based on 68-week trials, the most frequently reported adverse events with Wegovy(tm) were nausea, diarrhea, vomiting, constipation, and abdominal pain.2 In the STEP 5 trial, the safety profile of Wegovy(tm) was in line with previous STEP phase 3a trials; 5.9% of patients treated with Wegovy(tm) and 4.6% of patients treated with placebo permanently discontinued treatment as a result of adverse events.1

"Obesity is a chronic disease associated with at least 60 other health conditions and decreased life expectancy. With Wegovy(tm), we have a significant opportunity to drive meaningful change in how obesity is treated," said Doug Langa, Executive Vice President, North America Operations and President of Novo Nordisk Inc. "We are making strides by bringing an important option forward that can help people with obesity. The interest from patients and healthcare professionals is truly humbling and underscores how great this unmet need really is, as well as our responsibility to the obesity community."

About Wegovy(tm)

Wegovy(tm) is a GLP-1 receptor agonist. Wegovy(tm) was approved by the U.S. Food and Drug Administration on June 4, 2021. It is currently under review in the European Union and other countries.2,3

What is Wegovy(tm)?

Wegovy(tm) (semaglutide) injection 2.4 mg is an injectable prescription medicine used for adults with obesity (BMI ?30) or overweight (excess weight) (BMI ?27) who also have weight-related medical problems to help them lose weight and keep the weight off.

* Wegovy(tm) should be used with a reduced calorie meal plan and increased physical activity.

* Wegovy(tm) contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.

* It is not known if Wegovy(tm) is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products.

* It is not known if Wegovy(tm) can be used safely in people with a history of pancreatitis.

* It is not known if Wegovy(tm) is safe and effective for use in children under 18 years of age.

Important Safety Information

What is the most important information I should know about Wegovy(tm)?

Wegovy(tm) may cause serious side effects, including:

* Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy(tm) and medicines that work like Wegovy(tm) caused thyroid tumors, including thyroid cancer. It is not known if Wegovy(tm) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.

* Do not use Wegovy(tm) if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Do not use Wegovy(tm) if:

* you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

* you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy(tm).

Before using Wegovy(tm), tell your healthcare provider if you have any other medical conditions, including if you:

* have or have had problems with your pancreas or kidneys.

* have type 2 diabetes and a history of diabetic retinopathy.

* have or have had depression, suicidal thoughts, or mental health issues.

* are pregnant or plan to become pregnant. Wegovy(tm) may harm your unborn baby. You should stop using Wegovy(tm) 2 months before you plan to become pregnant.

* are breastfeeding or plan to breastfeed. It is not known if Wegovy(tm) passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy(tm) may affect the way some medicines work and some medicines may affect the way Wegovy(tm) works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy(tm) slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

What are the possible side effects of Wegovy(tm)?

Wegovy(tm) may cause serious side effects, including:

* inflammation of your pancreas (pancreatitis). Stop using Wegovy(tm) and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

* gallbladder problems. Wegovy(tm) may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.

* increased risk of low blood sugar (hypoglycemia) in patients with type 2 diabetes, especially those who also take medicines for type 2 diabetes such as sulfonylureas or insulin. This can be both a serious and common side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy(tm). Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery.

* kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.

* serious allergic reactions. Stop using Wegovy(tm) and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.

* change in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy(tm).

* increased heart rate. Wegovy(tm) can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes.

* 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 healthcare provider right away if you have any mental changes that are new, worse or worry you.

* the most common side effects of Wegovy(tm) may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, gas, stomach flu and heartburn.

Please see Prescribing Information, including Medication Guide, at https://www.novo-pi.com/wegovy.pdf