Wegovy Demonstrated Significant and Sustained Weight Loss Over Two Years in Phase 3b STEP 5 Trial

Novo Nordisk recently announced the results of a Phase 3b clinical trial (STEP 5) of its novel obesity medication Wegovy (semaglutide, 2.4 mg subcutaneous injection) at the ObesityWeek® 2021 conference. The trial enrolled 304 adult patients with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) to evaluate the efficacy and safety of Wegovy versus placebo for the treatment of obesity or overweight. Both interventions were administered in combination with a reduced-calorie diet and increased physical activity over a 104-week (2-year) treatment period. The data showed that adult patients receiving Wegovy achieved significant and sustained weight loss during the 2-year study period.

Specifically, compared with the placebo group, patients in the Wegovy treatment group experienced significantly greater weight loss from baseline to week 104 (−15.2% vs −2.6%; treatment difference: −12.6% [95% CI: −15.3, −9.8]; p < 0.0001). Furthermore, the study demonstrated that a significantly higher proportion of patients in the Wegovy group achieved weight loss ≥5% compared with the placebo group (77.1% vs 34.4%; p < 0.0001). Based on multiple previous 68-week trials, the most commonly reported adverse events with Wegovy were nausea, diarrhea, vomiting, constipation, and abdominal pain. In the STEP 5 trial, the safety profile of Wegovy was consistent with that of the previous STEP 3a trial; 5.9% of patients in the Wegovy group and 4.6% in the placebo group permanently discontinued treatment due to adverse events.

Dr. W. Timothy Garvey, Professor and Chair of the Department of Nutritional Sciences at the University of Alabama at Birmingham, stated: “Patients with obesity attempt to lose weight an average of seven times before seeking medical care. However, weight is frequently regained after initial loss, which is why it is critical to find strategies that can help patients with obesity lose weight and maintain that weight loss. The results of the STEP 5 trial demonstrate that adults with obesity treated with Wegovy for two years were able to achieve and sustain weight loss. This enables us to better treat and manage obesity as a chronic disease.”

Doug Langa, President and Executive Vice President of North America Operations at Novo Nordisk, stated: "Obesity is a chronic disease associated with at least 60 other health conditions and reduced life expectancy. The marketing approval of Wegovy provides us with a significant opportunity to drive a meaningful shift in how obesity is treated."

Obesity is a chronic disease that requires long-term treatment, and it is associated with numerous serious health consequences and reduced life expectancy. There are many obesity-related complications, including type 2 diabetes, heart disease, obstructive sleep apnea, chronic kidney disease, nonalcoholic fatty liver disease, and cancer.

This June, the U.S. FDA approved Wegovy (semaglutide, 2.4 mg subcutaneous injection), a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated for long-term weight management. The drug is specifically indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. From a regulatory standpoint, Novo Nordisk submitted a Priority Review Voucher (PRV) to expedite the review process.

Notably, Wegovy is the first and only once-weekly GLP-1 receptor agonist approved for weight management in patients with obesity. This approval was based on results from the Phase III STEP clinical trial program, which involved more than 4,500 adult patients with obesity or overweight. In clinical trials conducted in subjects without type 2 diabetes, patients with obesity treated with Wegovy achieved an average weight loss of 17–18% over 68 weeks. Throughout the program, Wegovy was safe and well-tolerated, with gastrointestinal adverse reactions being the most common.

In the United States, the regulatory approval and market launch of Wegovy have brought tremendous hope to individuals living with obesity. Despite their best efforts to lose weight, many individuals with obesity still struggle to achieve and maintain weight loss due to physiological responses that favor weight regain. As a weight-loss medication with unprecedented efficacy, Wegovy marks a new era in the treatment of obesity.

Semaglutide is a human glucagon-like peptide-1 (GLP-1) analogue that stimulates insulin secretion and inhibits glucagon secretion in a glucose-dependent manner. It significantly improves blood glucose levels in patients with type 2 diabetes mellitus with a low risk of hypoglycemia. Additionally, semaglutide induces weight loss by reducing appetite and decreasing food intake. Furthermore, semaglutide significantly reduces the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes.

In China, Nuohetai® (English trade name: Ozempic; semaglutide; semaglutide injection; formerly provisionally named: somarulide) was approved by the National Medical Products Administration (NMPA) in April this year for the treatment of patients with type 2 diabetes (T2D) to improve glycemic control. Nuohetai® is a novel long-acting glucagon-like peptide-1 (GLP-1) analog with a half-life of up to 7 days, suitable for once-weekly injection with stable plasma drug concentrations.

In China, the number of individuals with diabetes exceeds 129.8 million, yet only 15.8% achieve target glycemic control. Diabetes predisposes patients to macrovascular and microvascular complications, as well as other complications, severely compromising quality of life and increasing the disease burden. Notably, cardiovascular disease is the leading cause of mortality in patients with type 2 diabetes mellitus. In China, 1 in 3 patients with diabetes has cardiovascular disease. Suboptimal glycemic control, coupled with inadequate management of cardiovascular metabolic parameters such as blood pressure, blood lipids, and body weight, is the primary driver of the high complication rates among diabetic patients in China. Therefore, diabetes treatment must focus on comprehensive patient benefits by balancing glycemic control with cardiovascular outcomes and implementing comprehensive management of multiple risk factors.

As a once-weekly blockbuster GLP-1 product, Ozempic® leverages breakthrough technology to extend its half-life to 7 days, enabling once-weekly administration. It delivers potent glycemic control, ensures precise target attainment, and provides comprehensive cardiovascular and metabolic benefits, offering Chinese patients with type 2 diabetes a more effective, convenient, and safe treatment option. The approval of Ozempic® will further drive the transformation of diabetes treatment modalities and paradigms in China, facilitate comprehensive disease management, improve long-term clinical outcomes, and help patients return to a life of ease and balance.

Original Source:Wegovy demonstrated significant and sustained weight loss in two-year study in adults with obesity