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 How Semaglutide Works in People With Type 2 Diabetes in France, as Part of Local Clinical Practice (SURE FRANCE)

Completed
Conditions
Interventions
First Posted Date
2019-09-10
Last Posted Date
2023-03-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
521
Registration Number
NCT04083820
Locations
🇫🇷

Novo Nordisk Investigational Site, Yerres, France

Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

First Posted Date
2019-08-29
Last Posted Date
2023-05-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
338
Registration Number
NCT04074161
Locations
🇺🇸

Novo Nordisk Investigational Site, Olympia, Washington, United States

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

Completed
Conditions
Interventions
First Posted Date
2019-08-28
Last Posted Date
2021-09-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
230
Registration Number
NCT04067999
Locations
🇪🇸

Novo Nordisk Investigational Site, Álava, Spain

A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes

First Posted Date
2019-07-25
Last Posted Date
2024-05-03
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
101
Registration Number
NCT04032197
Locations
🇦🇹

Clinical Trials Unit / Center for Medical Research, Graz, Austria

🇸🇪

CTC Clinical Trial Consultants AB, Uppsala, Uppsala, Sweden

🇩🇰

Steno Diabetes Center Copenhagen, Herlev, Denmark

and more 1 locations

A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

First Posted Date
2019-06-18
Last Posted Date
2023-02-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
961
Registration Number
NCT03989232
Locations
🇺🇦

Novo Nordisk Investigational Site, Zhytomyr, Ukraine

A Research Study on How Semaglutide Works in People With Fatty Liver Disease and Liver Damage

First Posted Date
2019-06-17
Last Posted Date
2024-05-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
71
Registration Number
NCT03987451
Locations
🇺🇸

Texas Clinical Research Institute, LLC, Arlington, Texas, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

University of Miami/Schiff Center for Liver Diseases, Miami, Florida, United States

and more 35 locations

A Study of Tirzepatide (LY3298176) Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Participants With Type 2 Diabetes

Phase 3
Completed
Conditions
Interventions
First Posted Date
2019-06-17
Last Posted Date
2022-02-14
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1879
Registration Number
NCT03987919
Locations
🇺🇸

PharmQuest, Greensboro, North Carolina, United States

🇺🇸

Aventiv Research Inc, Columbus, Ohio, United States

🇺🇸

Biopharma Informatic, Inc., Houston, Texas, United States

and more 117 locations

Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

First Posted Date
2019-06-14
Last Posted Date
2021-07-15
Lead Sponsor
Gilead Sciences
Target Recruit Count
109
Registration Number
NCT03987074
Locations
🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Institute for Liver Health - Arizona Liver Health, Chandler, Arizona, United States

🇺🇸

Quality Medical Research, PLLC, Nashville, Tennessee, United States

and more 14 locations

A Study of Tirzepatide in Participants With Type 2 Diabetes Mellitus (T2DM)

First Posted Date
2019-05-15
Last Posted Date
2023-03-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
117
Registration Number
NCT03951753
Locations
🇩🇪

Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, Germany

🇩🇪

Profil Mainz GmbH & Co. KG, Mainz, Rheinland-Pfalz, Germany

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in The Netherlands, as Part of Local Clinical Practice (SURE NETHERLANDS)

Completed
Conditions
Interventions
First Posted Date
2019-04-29
Last Posted Date
2023-01-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
218
Registration Number
NCT03929679
Locations
🇳🇱

Novo Nordisk Investigational Site, Zwijndrecht, Netherlands

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