Semaglutide

Generic Name
Semaglutide
Brand Names
Ozempic, Rybelsus, Wegovy
Drug Type
Small Molecule
Chemical Formula
C187H291N45O59
CAS Number
910463-68-2
Unique Ingredient Identifier
53AXN4NNHX
Background

Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. Other members of this drug class include Exenatide and Liraglutide. Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017. The tablet formulation was approved for oral administration in September 2019. Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose.

The subcutaneous injection is administered once weekly and the tablet is administered once a day. Semaglutide offers a competitive advantage over other drugs used to manage diabetes, which may require several daily doses. Clinical trials have determined that this drug reduces glycosylated hemoglobin (HbA1c) levels and reduces body weight, proving to be effective for patients with type 2 diabetes. In June 2021, semaglutide was approved by the FDA for chronic weight management in adults with general obesity or overweight who have at least one weight-related condition, marking semaglutide as the first approved drug for such use since 2014. The use of semaglutide in weight management is also approved by Health Canada and the EMA.

On May 31, 2023, the FDA issued a warning regarding the use of compounded semaglutide after receiving adverse event reports. The use of salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, has not been proven to be safe or effective.

Indication

Semaglutide is indicated to improve glycemic control in adults diagnosed with type 2 diabetes mellitus, and is used as an adjunct to diet and exercise. However, semaglutide is not a suitable first-line drug for diabetes that has not been controlled by diet and exercise. In addition, it has not been studied in patients with pancreatitis. Semaglutide is not intended for use in patients with type 1 diabetes or to treat diabetic ketoacidosis.

Semaglutide is indicated for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced-calorie diet and increased physical activity.. Semaglutide it is also indicated for chronic weight management in pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex.

Associated Conditions
BMI >27 kg/m2, Cardiovascular Events, Obesity, Type 2 Diabetes Mellitus
Associated Therapies
Chronic Weight Management therapy

A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

Phase 1
Completed
Conditions
Interventions
First Posted Date
2020-01-14
Last Posted Date
2022-01-10
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
28
Registration Number
NCT04228354
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

First Posted Date
2020-01-02
Last Posted Date
2024-10-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
51
Registration Number
NCT04216589
Locations
🇺🇸

Ohio State University CRS (Site ID: 2301), Columbus, Ohio, United States

🇺🇸

Houston AIDS Research Team CRS (Site ID: 31473), Houston, Texas, United States

🇺🇸

University of Washington AIDS CRS (Site ID: 1401), Seattle, Washington, United States

and more 6 locations

Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc

First Posted Date
2019-12-06
Last Posted Date
2022-11-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
104
Registration Number
NCT04189848
Locations
🇳🇱

Novo Nordisk Investigational Site, Groningen, Netherlands

A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-12-05
Last Posted Date
2021-11-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
68
Registration Number
NCT04187300
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

Real-world Health Outcomes in Canadian Patients Using Semaglutide

Completed
Conditions
First Posted Date
2019-11-25
Last Posted Date
2020-02-21
Lead Sponsor
LMC Diabetes & Endocrinology Ltd.
Target Recruit Count
1133
Registration Number
NCT04175665
Locations
🇨🇦

LMC Diabetes & Endocrinology, Toronto, Ontario, Canada

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

First Posted Date
2019-11-06
Last Posted Date
2022-11-29
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
413
Registration Number
NCT04153929
Locations
🇺🇸

Javara Research, Sugar Land, Texas, United States

🇺🇸

San Marcus Research Clinic, Inc., Miami, Florida, United States

🇬🇧

Burbage Surgery, Burbage, Hinkley, United Kingdom

and more 74 locations

A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens

First Posted Date
2019-11-05
Last Posted Date
2021-11-10
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
68
Registration Number
NCT04152915
Locations
🇩🇪

Novo Nordisk Investigational Site, Mainz, Germany

Impact of Semaglutide on CD34+ EPC and Fat Derived MSC

Phase 4
Completed
Conditions
Interventions
First Posted Date
2019-10-15
Last Posted Date
2024-04-26
Lead Sponsor
Sabyasachi Sen
Target Recruit Count
38
Registration Number
NCT04126603
Locations
🇺🇸

Washington VA Medical Center, Washington, District of Columbia, United States

🇺🇸

The GW Medical Faculty Associates, Washington, District of Columbia, United States

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-09-25
Last Posted Date
2024-01-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
201
Registration Number
NCT04102189
Locations
🇬🇧

Novo Nordisk Investigational Site, Southampton, United Kingdom

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Italy, as Part of Local Clinical Practice

Completed
Conditions
Interventions
First Posted Date
2019-09-19
Last Posted Date
2023-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
581
Registration Number
NCT04094415
Locations
🇮🇹

Novo Nordisk Investigational Site, Vigevano, Italy

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