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.
New Dosage	NCT04287179 ↗	SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2020-03-09	This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.
New Dosage	NCT06083675 ↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

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.
NCT00851773 ↗	Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects	Completed	Novo Nordisk A/S	Phase 1	2009-02-01	This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.
NCT01272973 ↗	Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects	Completed	Novo Nordisk A/S	Phase 1	2011-01-01	This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects

Clinical Trial Conditions for Semaglutide

Condition Name

Condition Name for Semaglutide
Intervention	Trials
Diabetes Mellitus, Type 2	107
Obesity	66
Diabetes	64
Healthy	26

Condition MeSH

Condition MeSH for Semaglutide
Intervention	Trials
Diabetes Mellitus, Type 2	134
Diabetes Mellitus	122
Obesity	57
Overweight	42

Clinical Trial Locations for Semaglutide

Trials by Country

Trials by Country for Semaglutide
Location	Trials
India	225
China	159
Canada	155
South Africa	96
Mexico	90

Trials by US State

Trials by US State for Semaglutide
Location	Trials
California	72
Texas	71
Florida	61
North Carolina	61
New York	51

Clinical Trial Progress for Semaglutide

Clinical Trial Phase

Clinical Trial Phase for Semaglutide
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	94
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Semaglutide
Clinical Trial Phase	Trials
Completed	101
Not yet recruiting	94
Recruiting	74

Clinical Trial Sponsors for Semaglutide

Sponsor Name

Sponsor Name for Semaglutide
Sponsor	Trials
Novo Nordisk A/S	186
University of Colorado, Denver	7
Eli Lilly and Company	5

Sponsor Type

Sponsor Type for Semaglutide
Sponsor	Trials
Industry	206
Other	177
NIH	14

Semaglutide: Clinical Trials, Market Analysis, and Projections

Introduction to Semaglutide

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been making significant waves in the medical and pharmaceutical industries due to its multifaceted benefits, particularly in managing type 2 diabetes, obesity, and cardiovascular diseases.

Clinical Trials Update

Cardiovascular Outcomes

A recent international multicenter, randomized, double-blind, placebo-controlled trial involving 17,604 patients with overweight or obesity and established cardiovascular disease (CVD) has shown promising results for semaglutide. The trial, which had a mean follow-up duration of 40 months, demonstrated that once-weekly subcutaneous semaglutide significantly reduced the risk of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, compared to placebo. The hazard ratio (HR) for MACE was 0.80 (95% CI 0.72-0.90, p < 0.001)[1].

Heart Failure

The same trial highlighted that semaglutide was associated with decreased MACE, heart failure hospitalization, and cardiovascular death in patients with heart failure, whether it was heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF). There was no significant interaction with the heart failure subtype, and the adverse event profiles were similar to the overall cohort[1].

Other Indications

Novo Nordisk is also conducting Phase III clinical trials to explore semaglutide's efficacy in early Alzheimer's disease, with results expected in late 2026. Additionally, semaglutide has shown a 24% reduction in the risk of kidney disease-related events, prompting plans for regulatory approval in the U.S. and Europe in 2024[3].

Comparative Studies

A study comparing semaglutide and tirzepatide, another GLP-1 receptor agonist, in adults with overweight or obesity found that while both medications are effective for weight loss, tirzepatide may produce greater weight loss in some populations. However, the study also noted that actual adherence and treatment effects in clinical settings may differ from those in randomized controlled trials[4].

Market Analysis

Current Market Size

As of 2024, the semaglutide market size is estimated to be approximately USD 27.55 billion. This figure is part of a larger trend that sees the market growing at a compound annual growth rate (CAGR) of 12.80% from 2024 to 2029, projected to reach USD 50.34 billion by 2029[2].

Regional Market Performance

North America currently holds the largest market share for semaglutide, while the Asia Pacific region is expected to be the fastest-growing market during the forecast period. Europe is also anticipated to show significant growth due to the rising incidence of type 2 diabetes and obesity[2][5].

Key Players

Novo Nordisk A/S is one of the major companies operating in the semaglutide market. The company's initiatives, such as the "Cities Changing Diabetes" program, aimed at identifying and addressing diabetes risk globally, further support market growth[5].

Market Projections

Growth Drivers

The growing prevalence of diabetes and obesity worldwide is a significant driver for the semaglutide market. Government initiatives and campaigns for diabetes prevention and control also contribute to the market's expansion. The APAC region, in particular, is expected to grow at the highest CAGR due to rapid urbanization and changing lifestyles[2][5].

Future Outlook

By 2032, the global semaglutide market is predicted to be worth USD 165 million, growing at a CAGR of 5.2% from 2024 to 2032. This growth is fueled by the increasing demand for effective treatments for diabetes and obesity, as well as the drug's potential in managing other conditions such as kidney disease and Alzheimer's[5].

Adverse Events and Safety Profile

Clinical trials have shown that while semaglutide is generally safe, it is associated with certain adverse events. Gastrointestinal complications are more common with semaglutide compared to placebo, and the drug can also lead to adverse events that result in trial drug discontinuation. However, serious adverse events such as acute pancreatitis and acute kidney failure were not significantly different between the semaglutide and placebo groups[1].

Expert Insights and Quotes

"GLP-1s’ ability to treat such wide-ranging diseases is nonetheless driving their expanding reach," notes an industry expert, highlighting the versatile therapeutic potential of semaglutide and other GLP-1 receptor agonists[3].

Illustrative Statistics

• Market Size (2024): USD 27.55 billion[2]
• Projected Market Size (2029): USD 50.34 billion[2]
• CAGR (2024-2029): 12.80%[2]
• Percentage of Patients Achieving Target Dose: 77%[1]
• Mean Change in Body Weight at 104 Weeks: –9.4% vs. –0.9% for semaglutide vs. placebo[1]
• Reduction in Kidney Disease-Related Events: 24%[3]

Key Takeaways

• Semaglutide has demonstrated significant reductions in cardiovascular events and heart failure hospitalizations.
• The drug is expanding its therapeutic reach to include kidney disease, Alzheimer's, and other conditions.
• The semaglutide market is expected to grow substantially, driven by increasing demand for diabetes and obesity treatments.
• North America holds the largest market share, while the Asia Pacific region is the fastest-growing market.
• Adverse events, particularly gastrointestinal complications, are more common with semaglutide but do not significantly impact its safety profile.

FAQs

What are the primary clinical benefits of semaglutide?

Semaglutide significantly reduces the risk of major adverse cardiovascular events, including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. It also decreases heart failure hospitalization and cardiovascular death in patients with heart failure.

Which regions are expected to drive the growth of the semaglutide market?

The Asia Pacific region is expected to be the fastest-growing market, while North America currently holds the largest market share. Europe is also anticipated to show significant growth.

What are the common adverse events associated with semaglutide?

Common adverse events include gastrointestinal complications, which are more frequent with semaglutide compared to placebo. However, serious adverse events such as acute pancreatitis and acute kidney failure are not significantly different between the semaglutide and placebo groups.

What is the current market size of semaglutide, and what is its projected growth?

The current market size of semaglutide is estimated at USD 27.55 billion in 2024, and it is projected to reach USD 50.34 billion by 2029, growing at a CAGR of 12.80%.

Which companies are major players in the semaglutide market?

Novo Nordisk A/S is one of the major companies operating in the semaglutide market.

What are the future therapeutic indications being explored for semaglutide?

Future indications include early Alzheimer's disease, kidney disease, and nonalcoholic steatohepatitis (NASH), among others.

Sources

1. American College of Cardiology: "Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity and Established CVD"[1]
2. Mordor Intelligence: "Semaglutide Market Size & Share Analysis - Industry Research Report"[2]
3. BioSpace: "Beyond Weight Loss: Novo and Lilly Look to Expand Their GLP-1 Pipelines"[3]
4. JAMA Internal Medicine: "Semaglutide vs Tirzepatide for Weight Loss in Adults With Overweight or Obesity"[4]
5. Market Data Forecast: "Semaglutide Market Size, Share, Growth & Trends Report, 2032"[5]

Last updated: 2024-12-31