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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

Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: semaglutide
Drug: placebo
Drug: Microgyn®
First Posted Date
2011-03-29
Last Posted Date
2017-02-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
43
Registration Number
NCT01324505
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Healthy
Interventions
Drug: semaglutide
Drug: placebo
First Posted Date
2011-01-10
Last Posted Date
2015-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
96
Registration Number
NCT01272973

Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
Drug: placebo
Drug: semaglutide
First Posted Date
2009-02-26
Last Posted Date
2015-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
84
Registration Number
NCT00851773

Effect of Renal Impairment on the Pharmacokinetics of NN9535

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Renal Impairment
Diabetes
Interventions
First Posted Date
2009-02-02
Last Posted Date
2017-04-04
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
62
Registration Number
NCT00833716
Locations
🇺🇸

Novo Nordisk Investigational Site, Knoxville, Tennessee, United States

A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
First Posted Date
2008-12-22
Last Posted Date
2015-02-23
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
44
Registration Number
NCT00813020

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Phase 2
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-06-13
Last Posted Date
2019-08-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
415
Registration Number
NCT00696657
Locations
🇬🇧

Novo Nordisk Investigational Site, Trowbridge, United Kingdom

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