CLINICAL TRIALS PROFILE FOR WEGOVY

All Clinical Trials for Wegovy

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05071898 ↗	Pharmacogenetics of Response to GLP1R Agonists	Not yet recruiting	University of Maryland, Baltimore	Phase 1	2021-12-01	Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims: 1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug). 2. Specific Aim #2. To identify genetic variants associated with the effect of a GLP1R agonist to accelerate the rate of glucose disappearance as assessed in the two FSIGTs (before and after administration of drug). Genotyping will be conducted using a high-density array with comprehensive coverage of DNA sequence variants. In addition, the analysis will leverage a global imputation panel generated from 1,025 Amish individuals.
NCT05254314 ↗	Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)	Not yet recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2022-05-01	This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. We will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory tract in adult asthma associated with obesity.
NCT05254314 ↗	Glucagon-Like Peptide-1 Receptor Agonist in the Treatment of Adult, Obesity-related, Symptomatic Asthma (GATA-3)	Not yet recruiting	Vanderbilt University Medical Center	Phase 2	2022-05-01	This is a randomized placebo-controlled trial of semaglutide, an FDA-approved therapy for the treatment of type 2 diabetes mellitus and obesity, in adults with symptomatic asthma despite the use of inhaled steroids and with excess body weight. We will test the central hypothesis that semaglutide will improve asthma control and reduce airway inflammation due to direct effects on the respiratory tract in adult asthma associated with obesity.
NCT05424003 ↗	Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant	Not yet recruiting	Novo Nordisk A/S	Phase 2	2022-07-01	In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a "sugar pill") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.
NCT05424003 ↗	Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant	Not yet recruiting	Virginia Commonwealth University	Phase 2	2022-07-01	In this study, semaglutide will be compared to placebo (a look-alike inactive substance, a "sugar pill") to determine if its use will prevent weight gain after liver transplantation (LT). In addition, researchers will be testing to determine if semaglutide prevents the development of Non-Alcoholic Fatty Liver Disease (NAFLD) after transplant through Magnetic Resonance Imaging (MRI) and laboratory results.
NCT05548647 ↗	Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects	Recruiting	Novo Nordisk A/S	Phase 4	2022-07-26	This study will evaluate the effect of semaglutide on eating behavior, appetite (hunger/fullness), and food liking in the long-term, as compared to placebo. All participants will receive lifestyle modification (diet and exercise) counseling, and will be prescribed the FDA-approved weight loss medication, semaglutide, or placebo (an inactive saline solution) for 72 weeks.
NCT05548647 ↗	Semaglutide Treatment, Appetite, and Eating Behavior: Long-term Effects	Recruiting	University of Pennsylvania	Phase 4	2022-07-26	This study will evaluate the effect of semaglutide on eating behavior, appetite (hunger/fullness), and food liking in the long-term, as compared to placebo. All participants will receive lifestyle modification (diet and exercise) counseling, and will be prescribed the FDA-approved weight loss medication, semaglutide, or placebo (an inactive saline solution) for 72 weeks.

Clinical Trial Conditions for Wegovy

Condition Name

Condition Name for Wegovy
Intervention	Trials
Obesity	6
NAFLD	2
Non-alcoholic Fatty Liver Disease	2
Chronic Obstructive Pulmonary Disease	1

Condition MeSH

Condition MeSH for Wegovy
Intervention	Trials
Obesity	5
Diabetes Mellitus, Type 2	2
Non-alcoholic Fatty Liver Disease	2
Liver Diseases	2

Clinical Trial Locations for Wegovy

Trials by Country

Trials by Country for Wegovy
Location	Trials
United States	4
Canada	1
Egypt	1
China	1

Trials by US State

Trials by US State for Wegovy
Location	Trials
Pennsylvania	2
Tennessee	1
Virginia	1

Clinical Trial Progress for Wegovy

Clinical Trial Phase

Clinical Trial Phase for Wegovy
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	5
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Wegovy
Clinical Trial Phase	Trials
Not yet recruiting	9
Recruiting	3

Clinical Trial Sponsors for Wegovy

Sponsor Name

Sponsor Name for Wegovy
Sponsor	Trials
Novo Nordisk A/S	3
University of Pennsylvania	2
University of Maryland, Baltimore	1

Sponsor Type

Sponsor Type for Wegovy
Sponsor	Trials
Other	12
Industry	5
NIH	1

Wegovy: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Wegovy

Wegovy, marketed by Novo Nordisk, is a prescribed injectable medication containing semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It is designed to aid in weight loss and weight management for individuals with obesity or those who are overweight with at least one weight-related medical condition.

Clinical Trials and Efficacy

Key Clinical Trials

The FDA's approval of Wegovy was based on the results of the Semaglutide Treatment Effect in People with Obesity (STEP) clinical trial program. This program included four 68-week, randomized, double-blind clinical trials involving approximately 4,500 participants who were either obese or overweight[1].

• Placebo-Controlled Trials: In Studies I, II, and III, patients were randomized to receive either Wegovy or a placebo. The results showed that 83.5%, 67.4%, and 84.8% of Wegovy-treated patients lost 5% or more of their body weight, compared to 31.1%, 30.2%, and 47.8% of placebo-treated patients at 68 weeks[1].

• Placebo-Withdrawal Trial: In this study, patients who reached the 2.4mg dose of Wegovy after a 20-week run-in period were randomized to continue Wegovy or receive a placebo for 48 weeks. The trial observed a 7.9% drop in body weight in the Wegovy group compared to a 6.9% reduction in the placebo group[1].

Long-Term Efficacy

A notable trial, the SELECT trial, evaluated the efficacy and safety of Wegovy over 208 weeks (almost four years). This trial demonstrated a mean weight reduction of 10.2% in the Wegovy arm versus 1.5% in the placebo arm. Additionally, there were significant reductions in waist circumference, waist-to-height ratio, and improvements in cardiometabolic risk factors[3].

Safety Profile

Wegovy has shown a safe and well-tolerated profile throughout the clinical trials. The most prevalent adverse events were gastrointestinal. The SELECT trial also highlighted that the rate of serious adverse events was lower in the Wegovy-treated arm compared to the placebo arm, particularly in individuals with higher BMI categories[3].

Market Analysis

Market Size and Growth

The Wegovy market is projected to grow significantly. As of 2024, the market size is estimated at USD 1.82 billion and is expected to reach USD 2.67 billion by 2029, growing at a CAGR of greater than 7% during the forecast period[2].

Geographic Segmentation

The market is segmented geographically, with North America holding the largest market share in 2024. However, the Asia Pacific region is expected to be the fastest-growing market over the forecast period[2].

Market Leaders

Novo Nordisk A/S is the dominant player in the Wegovy market. The market is highly consolidated, but it is anticipated to witness the entry of generic players by 2032 as the patent for Wegovy is set to expire[2].

Market Projections and Trends

Revenue Projections

Analysts project that Wegovy will reach $9 billion in revenue by 2024 and top $22.5 billion by 2030, according to Visible Alpha consensus[3].

Sales Targets

Novo Nordisk has significantly increased its sales targets for Wegovy, aiming for more than 25 billion Danish krone ($3.72 billion) in obesity sales by 2025. This is more than double their previous target, reflecting the strong demand and growth potential of the drug[5].

Supply and Demand

Despite initial supply chain issues, Novo Nordisk is confident in meeting the U.S. demand for Wegovy. Production capacity is expected to increase in 2023, addressing previous delays and shortages[5].

Competitive Landscape

Market Competition

The approval of Eli Lilly's Zepbound in November 2023 introduces a new competitor in the weight-loss medication market. However, Wegovy's established presence and strong clinical data are expected to maintain its market position[2].

Generic Entry

The market is anticipated to remain highly consolidated until the entry of generic players by 2032, following the expiration of the Wegovy patent[2].

Regulatory Updates

FDA Approvals and Expansions

In March 2024, the FDA expanded Wegovy's approval to include cardiovascular benefits in addition to its initial approval for obesity and weight management. This expansion is expected to further enhance the market potential of Wegovy[3].

Key Takeaways

• Clinical Efficacy: Wegovy has demonstrated significant weight loss and sustained weight management in clinical trials.
• Market Growth: The market is projected to grow at a CAGR of greater than 7% from 2024 to 2029.
• Geographic Dominance: North America holds the largest market share, but the Asia Pacific region is the fastest-growing.
• Revenue Projections: Analysts expect Wegovy to reach $22.5 billion in revenue by 2030.
• Supply Chain: Novo Nordisk is addressing supply chain issues to meet growing demand.
• Regulatory Updates: FDA approvals, including expanded indications for cardiovascular benefits, are expected to boost market potential.

FAQs

What is the current market size of Wegovy?

The Wegovy market size is estimated at USD 1.82 billion in 2024[2].

Who is the major player in the Wegovy market?

Novo Nordisk A/S is the dominant player in the Wegovy market[2].

What is the fastest-growing region for Wegovy?

The Asia Pacific region is estimated to be the fastest-growing market for Wegovy[2].

What are the primary adverse events associated with Wegovy?

The most prevalent adverse events associated with Wegovy are gastrointestinal[1].

What are the projected revenue figures for Wegovy by 2030?

Analysts project that Wegovy will reach $22.5 billion in revenue by 2030[3].

Sources

1. Clinical Trials Arena: Wegovy for the Treatment of Chronic Weight Management, US.
2. Mordor Intelligence: Wegovy Market Size & Share Analysis - Industry Research Report.
3. Visible Alpha: Major Clinical Data Unveiled for Novo Nordisk (NVO) Obesity Drug Wegovy.
4. Novo MedLink: Chronic Weight Results | Wegovy® (semaglutide) injection 2.4 mg.
5. FiercePharma: Novo Nordisk, citing strong Wegovy demand, doubles 2025 sales target to $3.72B.