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 to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

Phase 2
Completed
Conditions
Interventions
First Posted Date
2022-08-03
Last Posted Date
2024-11-05
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
245
Registration Number
NCT05486065
Locations
🇺🇸

Univ of Alabama Birmingham, Birmingham, Alabama, United States

🇺🇸

Velocity Clin Res Gardena, Gardena, California, United States

🇺🇸

First Valley Med Grp Lancaster, Lancaster, California, United States

and more 69 locations

A Study in North Macedonia Investigating Retrospective Data of Glucagon-like Peptide-1 (GLP-1) Participants With Type 2 Diabetes (T2D) in Real World Environment (RWE) Setting (MIRAGE)

Completed
Conditions
Interventions
First Posted Date
2022-07-21
Last Posted Date
2023-02-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
314
Registration Number
NCT05468632
Locations
🇲🇰

Novo Nordisk Investigational Site, Veles, North Macedonia

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

Completed
Conditions
Interventions
First Posted Date
2022-07-05
Last Posted Date
2024-11-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
465
Registration Number
NCT05443334
Locations
🇪🇸

Master Centre for Spain, Madrid, Spain

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

Completed
Conditions
Interventions
First Posted Date
2022-07-05
Last Posted Date
2024-07-26
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
50
Registration Number
NCT05443191
Locations
🇫🇮

Aava Lääkärikeskus - Aava Kamppi, Annankatu 32, 00100 Helsinki, Finland, Helsinki,, Finland

🇫🇮

Master Centre for Finland, Helsinki, Finland, Finland

🇫🇷

Master centre for France_Paris La défense cedex, Paris, La Défense, France

A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together

First Posted Date
2022-06-28
Last Posted Date
2024-04-03
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
20
Registration Number
NCT05435677
Locations
🇨🇳

Peking University Third Hospital, Northern branch, Beijing, Beijing, China

A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet

First Posted Date
2022-06-23
Last Posted Date
2024-08-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
152
Registration Number
NCT05429593
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Brandenburg, Germany

🇩🇪

Parexel International GmbH, Berlin, Germany

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

First Posted Date
2022-05-27
Last Posted Date
2024-12-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1200
Registration Number
NCT05394519
Locations
🇺🇸

John Muir Physicians Network, Concord, California, United States

🇺🇸

Headlands Research California, LLC, Escondido, California, United States

🇺🇸

St. Jos Heritage Hlthcr_Fllrtn, Fullerton, California, United States

and more 153 locations

Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

First Posted Date
2022-05-12
Last Posted Date
2024-03-29
Lead Sponsor
Mayo Clinic
Target Recruit Count
81
Registration Number
NCT05371496
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Semaglutide in Comorbid Schizophrenia Spectrum Disorder and Obesity

Not Applicable
Recruiting
Conditions
Interventions
First Posted Date
2022-04-18
Last Posted Date
2024-03-05
Lead Sponsor
Centre for Addiction and Mental Health
Target Recruit Count
92
Registration Number
NCT05333003
Locations
🇨🇦

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

© Copyright 2024. All Rights Reserved by MedPath