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 Oral Semaglutide Works in People With Type 2 Diabetes in Mexico, as Part of Local Clinical Practice

Completed
Conditions
Interventions
First Posted Date
2022-04-07
Last Posted Date
2024-05-30
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
187
Registration Number
NCT05316662
Locations
🇲🇽

Centro de Investigacion Clinica Endocrinologica de Jalisco, Guadalajara, Jalisco, Mexico

🇲🇽

CICEJ Centro de Investigacion Clinica Endocrinologica de Jalisco SC, Guadalajara, Jalisco, Mexico

Semaglutide to Reduce Atrial Fibrillation Burden

First Posted Date
2022-01-26
Last Posted Date
2022-10-27
Lead Sponsor
San Francisco Veterans Affairs Medical Center
Target Recruit Count
132
Registration Number
NCT05209165
Locations
🇺🇸

Veterans Affairs Medical Center San Francisco, San Francisco, California, United States

A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2022-01-21
Last Posted Date
2024-11-12
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
30
Registration Number
NCT05202353
Locations
🇳🇱

Amsterdam UMC, location VUMC, Amsterdam, Netherlands

Sit Less, Interact and Move More (SLIMM) 2 Study

First Posted Date
2021-12-30
Last Posted Date
2024-03-20
Lead Sponsor
Srinvasan Beddhu
Target Recruit Count
156
Registration Number
NCT05173714
Locations
🇺🇸

Stanford University, Stanford, California, United States

🇺🇸

University of Utah, Salt Lake City, Utah, United States

A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

First Posted Date
2021-12-06
Last Posted Date
2024-02-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
500
Registration Number
NCT05144984
Locations
🇺🇸

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

🇺🇸

Piedmont Healthcare/Research, Statesville, North Carolina, United States

🇺🇸

Brigham & Women's Hospital, Boston, Massachusetts, United States

and more 85 locations

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2021-11-15
Last Posted Date
2024-12-11
Lead Sponsor
The University of Texas Health Science Center, Houston
Target Recruit Count
300
Registration Number
NCT05119179
Locations
🇺🇸

UTHealth Clinical Research Unit (CRU) at UT Brownsville, Brownsville, Texas, United States

Effect Of Semaglutide In Coronary Atheroma Plaque

Phase 3
Not yet recruiting
Conditions
Interventions
First Posted Date
2021-10-08
Last Posted Date
2021-10-08
Lead Sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Target Recruit Count
120
Registration Number
NCT05071417

A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)

First Posted Date
2021-09-05
Last Posted Date
2024-05-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1262
Registration Number
NCT05035082
Locations
🇺🇸

Scripps Whittier Diabetes Inst, La Jolla, California, United States

🇺🇸

Baylor Scott & White Res Inst, Dallas, Texas, United States

🇺🇸

FDRC, Costa Mesa, California, United States

and more 21 locations

Comparing Semaglutide Versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus (SIB)

First Posted Date
2021-07-28
Last Posted Date
2023-06-13
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
42
Registration Number
NCT04979130
Locations
🇺🇸

University of Colorado Anschutz, Aurora, Colorado, United States

A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity

First Posted Date
2021-06-25
Last Posted Date
2024-02-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
40
Registration Number
NCT04940078
Locations
🇩🇰

Novo Nordisk Investigational Site, Søborg, Denmark

🇨🇦

Altasciences Company Inc., Montreal, Quebec, Canada

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