CLINICAL TRIALS PROFILE FOR SEMAGLUTIDE

505(b)(2) Clinical Trials for semaglutide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT03638778 ↗	Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men	Completed	Novo Nordisk A/S	Phase 1	2018-08-17	This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.
New Formulation	NCT04097600 ↗	A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets	Completed	Novo Nordisk A/S	Phase 1	2019-09-30	In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. One is the current formulation and the other one is a new formulation of semaglutide. Both will be administered as a tablet and are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. The tablet version of the study medicine is a new medicine that cannot yet be prescribed. Participants will either get semaglutide in the current tablet formulation previously tested in many large studies, or get the tablet that contains semaglutide in a new formulation - which treatment is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment in a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.
New Formulation	NCT04109508 ↗	A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets	Completed	Novo Nordisk A/S	Phase 1	2019-10-02	In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. Besides semaglutide, the current version of the tablet contains 300 mg SNAC and 3 helping agents, while the new version of the tablet contains 300 mg SNAC and only one helping agent. Both are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. Semaglutide cannot yet be prescribed as a tablet. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. Participants will get semaglutide in the current tablet formulation and in a new formulation - in which order they receive the two different formulations is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment for a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, they must take their breakfast 30-45 minutes after dosing.

All Clinical Trials for semaglutide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00696657 ↗	A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide	Completed	Novo Nordisk A/S	Phase 2	2008-06-03	This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.
NCT00813020 ↗	A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects	Completed	Novo Nordisk A/S	Phase 1	2009-01-01	This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.
NCT00833716 ↗	Effect of Renal Impairment on the Pharmacokinetics of NN9535	Completed	Novo Nordisk A/S	Phase 1	2009-02-02	This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.

Clinical Trial Conditions for semaglutide

Condition Name

Condition Name for semaglutide
Intervention	Trials
Diabetes Mellitus, Type 2	118
Obesity	114
Diabetes	66

Condition MeSH

Condition MeSH for semaglutide
Intervention	Trials
Diabetes Mellitus, Type 2	174
Diabetes Mellitus	130
Obesity	120

Clinical Trial Locations for semaglutide

Trials by Country

Trials by Country for semaglutide
Location	Trials
India	256
China	237
Canada	201
South Africa	105
Mexico	99

Trials by US State

Trials by US State for semaglutide
Location	Trials
California	95
Texas	94
Florida	86
North Carolina	76
New York	66

Clinical Trial Progress for semaglutide

Clinical Trial Phase

Clinical Trial Phase for semaglutide
Clinical Trial Phase	Trials
PHASE4	37
PHASE3	37
PHASE2	41

Clinical Trial Status

Clinical Trial Status for semaglutide
Clinical Trial Phase	Trials
Recruiting	128
Completed	120
Not yet recruiting	94

Clinical Trial Sponsors for semaglutide

Sponsor Name

Sponsor Name for semaglutide
Sponsor	Trials
Novo Nordisk A/S	211
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	10
University of Colorado, Denver	9

Sponsor Type

Sponsor Type for semaglutide
Sponsor	Trials
Other	291
Industry	276
NIH	27

Clinical Trials Update, Market Analysis, and Projection for Semaglutide

Last updated: October 27, 2025

Introduction

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has emerged as a cornerstone in the management of type 2 diabetes mellitus (T2DM) and obesity. Originally developed by Novo Nordisk, semaglutide enhances insulin secretion, suppresses glucagon release, and slows gastric emptying, thereby aiding glycemic control and weight loss. Its approval for multiple indications has expanded its therapeutic potential, fueling a dynamic clinical and commercial landscape. This article provides a comprehensive update on recent clinical trial data, analyzes market trends, and projects future growth trajectories for semaglutide.

Clinical Trials Update

Recent Clinical Developments

Over the past year, semaglutide's clinical development has seen significant activity, particularly in areas extending beyond its initial indications. Notably:

• SUSTAIN and STEP Program: The SUSTAIN series (including SUSTAIN 7, 8, and 9) continues to affirm semaglutide's efficacy in glycemic control and weight reduction. The STEP trials (Semaglutide Treatment Effect in People with Obesity) specifically target obesity management, demonstrating substantial weight loss.

• Weight Management and Obesity: The STEP 4 trial, a major phase 3 study, confirmed that weekly semaglutide (2.4 mg) significantly outperforms placebo in sustained weight loss over 68 weeks in overweight or obese adults without diabetes. Participants achieved an average weight reduction of approximately 15% of baseline body weight, surpassing other anti-obesity therapies.

• Cardiovascular Outcomes: The Select trial, currently underway, evaluates the long-term cardiovascular safety and benefits of semaglutide in patients with established cardiovascular disease and T2DM. Preliminary data suggest a promising reduction in major adverse cardiovascular events (MACE).

Expanding Indications

• Non-Alcoholic Fatty Liver Disease (NAFLD): A phase 2 trial assessing semaglutide's impact on hepatic steatosis and fibrosis showed promising initial results, prompting further trials to establish efficacy in NAFLD and non-alcoholic steatohepatitis (NASH).

• Type 1 Diabetes and Other Conditions: Early exploratory studies are assessing semaglutide's safety profile and potential benefits in type 1 diabetes, obesity-related hypertension, and appetite regulation disorders.

Regulatory Milestones

• FDA Approvals: Semaglutide, branded Wegovy for obesity and Ozempic for T2DM, received FDA approval in 2021 and 2019 respectively. These approvals have catalyzed its commercial adoption.

• Evolving Labeling and Dosage: The extension of dosing guidelines to include higher doses (up to 2.4 mg weekly) signifies ongoing optimization for weight management.

Ongoing and Future Trials

Multiple phase 3 and phase 4 trials are actively enrolling, focusing on combination therapies, long-term safety, and expanded indications, indicating sustained investment in semaglutide's clinical development pipeline.

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Market Analysis

Current Market Landscape

Semaglutide's dual approval for diabetes (Ozempic) and obesity (Wegovy) positions it as a dominant player within the GLP-1 receptor agonist class. The global diabetes therapeutics market was valued at approximately $54 billion in 2022, with an annual growth rate (CAGR) of around 7%[1].

Within this segment, semaglutide holds a significant share due to:

• Superior Efficacy: Clinical trials consistently demonstrate superior glycemic and weight loss outcomes versus competitors like dulaglutide and liraglutide.

• Patient Preference: Weekly subcutaneous dosing enhances adherence over daily injectables.

• Expanding Reach: Prevalence of T2DM and obesity continues to rise, amplifying demand.

Market Drivers and Challenges

• Drivers:

  1. Growing epidemiology: An estimated 537 million adults worldwide have diabetes, with obesity affecting over 650 million adults globally[2].
  2. Guideline endorsements: Major guidelines recommend GLP-1 receptor agonists as first-line or add-on treatments for T2DM and obesity.
  3. Expanded indications: Promising results in NASH and potential in type 1 diabetes may open new markets.

• Challenges:

  1. Pricing and reimbursement: High costs can limit access in certain markets.
  2. Competition: Emerging therapies like tirzepatide (a dual GIP/GLP-1 receptor agonist) show comparable or superior efficacy.
  3. Administration route: Subcutaneous delivery remains a barrier for some patients; upcoming formulations (e.g., oral semaglutide) may mitigate this.

Competitive Landscape

Key competitors include:

• Eli Lilly’s tirzepatide: Demonstrates superior glycemic and weight reduction in head-to-head trials, potentially threatening semaglutide’s market dominance.

• Other GLP-1 receptor agonists: Liraglutide, dulaglutide, and exenatide, although less efficacious in weight loss, continue to hold market share.

• Emerging oral formulations: Oral semaglutide (Rybelsus), approved for T2DM, is under investigation for obesity and NASH, representing future growth avenues.

Market Projections

Based on current adoption and pipeline activity, the global semaglutide market is projected to grow at a CAGR of 15-20% over the next five years, reaching approximately $15.7 billion by 2028, primarily driven by:

• Increased prevalence of T2DM and obesity.
• Broadened indications, especially in NASH.
• Launch of oral formulations enhancing patient compliance.
• Rising awareness and guideline endorsements.

Future Outlook and Strategic Considerations

The promising clinical pipeline suggests semaglutide will remain at the forefront of metabolic disease management, contingent on overcoming competitive pressures and reimbursement hurdles.

• Innovation: Further optimization (e.g., extended-release formulations, combination therapies) will enhance patient adherence and outcomes.
• Market Expansion: Strategies targeting emerging markets and underserved populations will be crucial.
• Partnerships and Biosimilars: Collaborations and potential entry of biosimilars post-patent expiry could influence pricing strategies.

Key Takeaways

• Robust Clinical Evidence: Semaglutide’s recent trials validate its efficacy in glycemic control, obesity management, and potentially NASH, supporting sustained growth.
• Rapid Market Penetration: Approval for multiple indications and convenient weekly dosing have facilitated rapid adoption, but competition from tirzepatide poses challenges.
• Expanding Indications: Future trials exploring NASH, cardiovascular outcomes, and oral formulations have the potential to transform its market footprint.
• Market Growth: The global semaglutide market is poised for substantial expansion, driven by the rising burden of metabolic diseases and ongoing pipeline milestones.
• Strategic Focus: Stakeholders should prioritize innovation, geographic expansion, and clinical validation to maintain competitive advantage.

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FAQs

1. What are the key benefits of semaglutide over other GLP-1 receptor agonists?
Semaglutide offers higher potency, longer half-life enabling weekly dosing, and superior efficacy in weight loss and glycemic control compared to earlier GLP-1 agents like liraglutide.

2. How does semaglutide compare to emerging therapies like tirzepatide?
Preliminary data demonstrate tirzepatide’s dual GIP/GLP-1 action may provide greater weight and glucose reductions, potentially challenging semaglutide’s market position. However, direct comparisons are ongoing.

3. What is the significance of oral semaglutide?
Oral semaglutide aims to improve patient adherence by offering a non-injectable option, expanding access, especially in markets with needle aversion.

4. What are the primary challenges facing semaglutide’s market growth?
Major hurdles include high costs, reimbursement barriers, competition from other novel agents, and the need for long-term safety data in new indications.

5. What is the outlook for semaglutide in treating NASH?
Early trials show promise, but definitive efficacy data are pending. Successful expansion into NASH could open a multibillion-dollar market segment.

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Sources

[1] Grand View Research. "Diabetes Therapeutics Market Size, Share & Trends Analysis Report," 2022.
[2] International Diabetes Federation. "IDF Diabetes Atlas, 10th Edition," 2021.