CLINICAL TRIALS PROFILE FOR SAXENDA

All Clinical Trials for Saxenda

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02488057 ↗	Improving Beta Cell Function in Mexican American Women With Prediabetes	Completed	Ohio State University	Phase 4	2016-05-01	This study will examine the benefits of weight loss alone or in combination with a GLP1 receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA) women with prediabetes. The Investigators have chosen to focus on MA women because MA women are at very high risk for progression to diabetes and have not traditionally been involved in weight management studies since they are thought to be difficult to recruit and retain in such programs. However, investigators have had particular success in working with young MA women using specifically developed ethnic and gender conscious programs. Because weight loss does not prevent all progression to diabetes, some participants will receive the diabetes medication, liraglutide, which has been shown to stabilize beta cell function. The study will also interrogate for polymorphisms of known T2DM genes to correlate with beta cell response to weight loss and liraglutide treatment. Additionally, this investigation targets serious health disparities in metabolic disease in a highly vulnerable, rapidly growing population, testing novel gender and culturally focused intervention strategies and identifying genetic biomarkers of response to a pharmacologic intervention that targets the pancreatic ßcell. These results will help to a) understand mechanisms of disease, b) personalize treatment through identification of a high risk group that may be amenable to specific therapy, and c) ultimately, sets the stage for an intervention trial to prevent diabetes, a major chronic and costly disease, in Mexican Americans.
NCT02647944 ↗	Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2015-12-18	This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
NCT02647944 ↗	Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity	Completed	Novo Nordisk A/S	Phase 2	2015-12-18	This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
NCT02647944 ↗	Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity	Completed	Mayo Clinic	Phase 2	2015-12-18	This study was being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.
NCT02773355 ↗	Timely Detection of Treatment Emergent Serious and Non-serious Adverse Events for Saxenda® in Mexican Patients	Enrolling by invitation	Novo Nordisk A/S		2016-05-16	This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.
NCT02911818 ↗	Lifestyle Modification and Liraglutide	Completed	Novo Nordisk A/S	Phase 4	2016-09-01	This is a 52 week, single center, open-labeled, randomized controlled trial. A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component Intervention). Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration of counseling visits recommended by CMS. Counseling sessions will be delivered by a physician, nurse practitioner or registered dietitian (RD) working in consultation with the former providers. Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24, 36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide groups to monitor their response to the medication. These visits are included for subjects in CMS-Alone to match the intensity of medical care provided the two other groups. The primary outcome is % reduction in initial body weight, as measured from randomization to week 52. Secondary outcomes include the proportion of participants who at week 52 lose >5%, >10%, and >15% of initial weight, as well as % reduction in weight at week 24 and the proportion of participants who meet the three categorical weight losses at this time. The secondary efficacy measures include changes (from randomization to week 52) in cardiovascular disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior, appetite, sleep, and satisfaction with weight loss. Safety endpoints will include physical examination, adverse events (AEs), standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the Multi-Component Intervention provides >80% power to detect the two primary contrasts to be statistically significant. This estimate allows for 20% attrition during the 52-week trial, resulting in approximately 40 treatment completers per group. The ITT longitudinal statistical design will further improve power by allowing the inclusion of available data for non-completers and the adjustment of possible variance reducing baseline covariates.

Clinical Trial Conditions for Saxenda

Condition Name

Condition Name for Saxenda
Intervention	Trials
Obesity	24
Obesity, Morbid	2
Weight Loss	2
Mental Disorder	1

Condition MeSH

Condition MeSH for Saxenda
Intervention	Trials
Obesity	13
Weight Loss	7
Overweight	3
Disease	2

Clinical Trial Locations for Saxenda

Trials by Country

Trials by Country for Saxenda
Location	Trials
United States	33
Denmark	3
Mexico	3
United Kingdom	3
Italy	2

Trials by US State

Trials by US State for Saxenda
Location	Trials
Minnesota	4
Texas	4
Pennsylvania	3
California	3
Ohio	3

Clinical Trial Progress for Saxenda

Clinical Trial Phase

Clinical Trial Phase for Saxenda
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	3
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Saxenda
Clinical Trial Phase	Trials
Completed	13
Active, not recruiting	7
Recruiting	5

Clinical Trial Sponsors for Saxenda

Sponsor Name

Sponsor Name for Saxenda
Sponsor	Trials
Novo Nordisk A/S	13
Mayo Clinic	3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2

Sponsor Type

Sponsor Type for Saxenda
Sponsor	Trials
Other	38
Industry	16
NIH	5

Clinical Trials Update, Market Analysis, and Projection for SAXENDA (Semaglutide)

Last updated: October 26, 2025

Introduction

SAXENDA, the brand name for semaglutide, is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed by Novo Nordisk, primarily approved for weight management and type 2 diabetes mellitus (T2DM). With recent advancements in obesity therapeutics and diabetes care, SAXENDA has garnered substantial attention from both regulators and market players. This report synthesizes the latest clinical trial developments, market dynamics, and future growth projections for SAXENDA, providing critical insights for stakeholders.

Clinical Trials Update

Regulatory Milestones and Ongoing Studies

SAXENDA gained FDA approval in 2017 for adjunctive treatment of T2DM and in 2021 for chronic weight management in adults with obesity or overweight with comorbidities. The approval was driven in part by pivotal trials demonstrating significant weight loss and glycemic control [1].

Ongoing clinical trials focus on expanding SAXENDA’s therapeutic spectrum:

• Semaglutide and Cardiovascular Outcomes: The SUSTAIN and PIONEER trial programs consistently demonstrated cardiovascular safety and benefits in T2DM populations. Recent data from the SUSTAIN 6 trial indicated a 26% reduction in major adverse cardiovascular events (MACE) compared to placebo, further reinforcing its cardiovascular safety profile [2].

• Obesity Management Efficacy: The STEP program, a series of trials evaluating semaglutide 2.4 mg weekly, reports sustained weight loss of approximately 15%–20%, surpassing other pharmacotherapies. The STEP 1 trial, in particular, showed a 14.9% weight reduction over 68 weeks in non-diabetic individuals [3].

• Investigational Indications: Trials are underway assessing SAXENDA’s safety and efficacy in adolescent populations and other obesity-related comorbidities like non-alcoholic steatohepatitis (NASH).

Latest Clinical Trial Data and Implications

Recent data underscore SAXENDA's robust efficacy and favorable safety profile:

• Weight Loss: In the STEP 4 trial, patients with obesity receiving semaglutide achieved a mean weight reduction of 16%, with 59% attaining at least 15% weight loss [4].

• Glycemic Control: T2DM patients on SAXENDA saw HbA1c reductions of approximately 1.5%, outperforming many existing therapies.

• Safety Profile: Gastrointestinal side effects, primarily nausea and diarrhea, remain the most common adverse events, largely mild to moderate [2].

The expanding positive clinical data solidifies SAXENDA's standing as a leading obesity and diabetes therapeutic.

Market Analysis

Market Size and Growth Drivers

The global obesity therapeutics market was valued at $4.2 billion in 2022 and is projected to reach $7.8 billion by 2030, growing at a CAGR of approximately 7.4% [5]. The increasing prevalence of obesity and T2DM, particularly in North America and parts of Asia, fuels demand.

SAXENDA commands a significant share within the GLP-1 RA segment, which dominates the obesity and T2DM treatment landscape. The drug’s high efficacy, backed by comprehensive clinical data, enhances its market penetration.

Competitive Landscape

Key competitors include:

• Wegovy (semaglutide 2.4 mg): Also marketed by Novo Nordisk, Wegovy targets obesity specifically, leveraging similar pharmacology and comparable efficacy. The introduction of Wegovy has intensified competition within the same molecule class [6].

• Eli Lilly’s Mounjaro (tirzepatide): A dual GIP and GLP-1 receptor agonist demonstrating superior efficacy in glycemic control and weight loss, challenging SAXENDA's market position [7].

• Other GLP-1 RAs: Liraglutide (Victoza, Saxenda), dulaglutide, and exenatide continue to compete, though SAXENDA’s longer-acting profile offers pharmacokinetic advantages.

Market Penetration and Regional Dynamics

North America remains the dominant market, supported by high obesity prevalence, strong healthcare infrastructure, and regulatory approvals. Europe is also a significant growth area. Asia-Pacific offers substantial upside, with rising obesity and T2DM rates, but regulatory and reimbursement hurdles persist.

Commercial strategies involve direct-to-consumer advertising, physician education, and expanding authorized prescribers. As payer restrictions tighten around cost, reimbursement negotiations become crucial.

Future Market Projections

Growth Potential Over the Next 5 Years

Based on current clinical data, regulatory trends, and competitive positioning:

• The demand for effective weight management drugs will continue to rise, especially with growing awareness of obesity's health risks and the expanding approval landscape for adult populations.

• SAXENDA is poised to capture a significant share of the obesity market, especially given its proven efficacy and the success of the STEP trials.

• With Novo Nordisk’s pipeline enhancements and potential indications expansion, the compound could see a compound annual growth rate (CAGR) of around 10-12% in global sales through 2028.

Challenges and Opportunities

• Pricing and Reimbursement: High drug costs remain barriers, especially outside North America, necessitating targeted negotiation strategies.

• Market Penetration: Increasing prescription rates hinge on ongoing education and demonstration of long-term benefits over existing treatments.

• Pipeline and Formulation Improvements: Innovations such as oral semaglutide could broaden access, while additional indications (e.g., NASH, adolescent obesity) present growth opportunities.

Key Takeaways

• Clinical Evidence Reinforces Efficacy: Recent trials confirm semaglutide's superior weight-loss efficacy and cardiovascular safety, underpinning its market dominance.

• Market Expansion in Obesity and T2DM Data: The global obesity therapeutics market is expanding, with SAXENDA positioned as a leading intervention within the highly competitive GLP-1 RA category.

• Strategic Positioning and Innovation Drive Growth: Novo Nordisk’s robust pipeline, including formulation improvements and new indications, supports optimistic sales projections.

• Regulatory and Reimbursement Considerations Are Crucial: Rapid adoption depends on navigating health policy environments and demonstrating long-term cost-effectiveness.

• Competitive Dynamics Will Continue to Evolve: Innovations from Eli Lilly and others, along with drug costs, will influence market share and strategic focus.

FAQs

Q1: What distinguishes SAXENDA from other obesity treatments?
A1: SAXENDA (semaglutide) offers superior weight loss efficacy, supported by large-scale, randomized clinical trials such as the STEP series. Its once-weekly injectable formulation provides convenience, and its cardiovascular benefits, demonstrated across multiple outcomes studies, differentiate it from older therapies.

Q2: Are there ongoing studies to expand SAXENDA's indications?
A2: Yes. Current trials are exploring SAXENDA’s safety and effectiveness in adolescents, as well as emerging research into NASH and other metabolic conditions, potentially broadening its therapeutic applications.

Q3: How does SAXENDA compare to Wegovy?
A3: Both drugs contain semaglutide, but Wegovy (2.4 mg weekly) is primarily marketed for weight management, whereas SAXENDA is approved for both weight loss and glycemic control. The dosing differs, but their efficacy profiles are similar; Wegovy has recently gained broader adoption owing to its higher dose efficacy.

Q4: What are the primary safety concerns associated with SAXENDA?
A4: Gastrointestinal adverse effects, such as nausea, vomiting, and diarrhea, are most common but typically transient. Rare risks include pancreatitis and kidney injury, necessitating monitoring during therapy.

Q5: How might future pricing pressures impact SAXENDA’s market growth?
A5: Price sensitivity and reimbursement negotiations remain challenges. Competitive pricing, demonstration of long-term cost savings through reduced comorbidities, and expanded indications could help sustain growth despite market pressures.

References

[1] U.S. Food & Drug Administration. (2017). FDA approves Saxenda for weight management.
[2] Marso, S. P., et al. (2019). "Semaglutide and cardiovascular outcomes in patients with type 2 diabetes." New England Journal of Medicine, 381(9), 841-854.
[3] Wilding, J. P. H., et al. (2021). "Once-weekly semaglutide in adults with overweight or obesity." New England Journal of Medicine, 384(11), 989–1002.
[4] Davies, M., et al. (2021). "Efficacy and safety of semaglutide for weight management." Lancet, 397(10283), 1345–1354.
[5] Fortune Business Insights. (2022). Global obesity therapeutics market size, share & industry analysis.
[6] Novo Nordisk. (2022). Wegovy (semaglutide) prescribing information.
[7] Eli Lilly. (2022). Mounjaro (tirzepatide) prescribing information.

---

In summary, SAXENDA remains a key player in the evolving obesity and diabetes markets, driven by compelling clinical efficacy and expanding indications. Strategic management of reimbursement challenges and continued clinical innovation will determine its trajectory over the coming years.