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

Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome

First Posted Date
2022-10-19
Last Posted Date
2024-01-05
Lead Sponsor
Georgios Papadakis
Target Recruit Count
150
Registration Number
NCT05586802
Locations
🇨🇭

Service of Endocrinology, Diabetes & Metabolism, Lausanne, Switzerland

A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in America

First Posted Date
2022-10-13
Last Posted Date
2024-01-31
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
500
Registration Number
NCT05579249
Locations
🇺🇸

Nutrition Research Centre, Loma Linda, California, United States

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

First Posted Date
2022-10-05
Last Posted Date
2024-12-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
3400
Registration Number
NCT05567796
Locations
🇦🇺

Momentum Clinical Research Darlinghurst, Darlinghurst, New South Wales, Australia

🇮🇹

Azienda Ospedaliera Universitaria Policlinico Umberto I, Roma, Italy

🇺🇸

Univ of Alabama Birmingham, Birmingham, Alabama, United States

and more 216 locations

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

First Posted Date
2022-10-03
Last Posted Date
2024-07-12
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
307
Registration Number
NCT05564117
Locations
🇺🇸

Washington Cntr Weight Mgmt, Arlington, Virginia, United States

🇩🇪

Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz, Lingen, Germany

🇵🇱

Centrum Zdrowia Metabolicznego, Poznan, Wielkopolskie Voivodeship, Poland

and more 19 locations

ADJUnct Semaglutide Treatment in Type 1 Diabetes

Phase 2
Completed
Conditions
Interventions
First Posted Date
2022-09-13
Last Posted Date
2024-08-27
Lead Sponsor
Viral N. Shah
Target Recruit Count
115
Registration Number
NCT05537233
Locations
🇺🇸

Iowa Diabetes Research Center, West Des Moines, Iowa, United States

🇺🇸

Henry Ford Hospital, Detroit, Michigan, United States

🇺🇸

Harold Schnitzer Diabetes Health Center, Portland, Oregon, United States

and more 1 locations

Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes

Phase 4
Completed
Conditions
Interventions
First Posted Date
2022-09-09
Last Posted Date
2024-08-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
100
Registration Number
NCT05533632
Locations
🇨🇱

Hospital San Juan de Dios_Santiago, Región Metropolitana, Santiago, Región Metropolitana, Chile

🇨🇱

Hospital Padre Hurtado, Santiago, Región Metropolitana, Chile

🇨🇱

Servicios Médicos Godoy Limitada, Santiago, Región Metropolitana, Chile

Effects of Semaglutide on Nicotine Intake

First Posted Date
2022-09-07
Last Posted Date
2024-08-15
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
24
Registration Number
NCT05530577
Locations
🇺🇸

University of North Carolina, Chapel Hill, North Carolina, United States

Semaglutide for Alcohol Use Disorder

First Posted Date
2022-08-30
Last Posted Date
2024-08-15
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
48
Registration Number
NCT05520775
Locations
🇺🇸

UNC-Chapel Hill, Chapel Hill, North Carolina, United States

A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE)

First Posted Date
2022-08-24
Last Posted Date
2024-11-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
568
Registration Number
NCT05514535
Locations
🇺🇸

Valley Research, Fresno, California, United States

🇺🇸

First Valley Medical Group, Lancaster, California, United States

🇺🇸

Loma Linda Univ Hlth Cr Endo, Loma Linda, California, United States

and more 108 locations

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men

First Posted Date
2022-08-12
Last Posted Date
2023-12-26
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
24
Registration Number
NCT05498610
Locations
🇨🇳

Novo Nordisk Investigational Site, Beijing, Beijing, China

© Copyright 2024. All Rights Reserved by MedPath