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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

Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
First Posted Date
2017-01-11
Last Posted Date
2021-01-15
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
243
Registration Number
NCT03018028
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2017-01-09
Last Posted Date
2021-03-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
458
Registration Number
NCT03015220
Locations
🇯🇵

Novo Nordisk Investigational Site, Yamato-shi, Kanagawa, Japan

A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
First Posted Date
2017-01-05
Last Posted Date
2017-12-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
41
Registration Number
NCT03010475
Locations
🇬🇧

Novo Nordisk Investigational Site, Harrow, United Kingdom

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Phase 2
Completed
Conditions
Hepatobiliary Disorders
Non-alcoholic Steatohepatitis
Interventions
Drug: Placebo
Drug: Semaglutide
First Posted Date
2016-11-22
Last Posted Date
2021-11-16
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
320
Registration Number
NCT02970942
Locations
🇬🇧

Novo Nordisk Investigational Site, Swansea, United Kingdom

A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
First Posted Date
2016-09-30
Last Posted Date
2017-12-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
45
Registration Number
NCT02920385
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
Drug: placebo
Drug: semaglutide
First Posted Date
2016-09-20
Last Posted Date
2022-07-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
703
Registration Number
NCT02906930
Locations
🇹🇷

Novo Nordisk Investigational Site, Istanbul, Turkey

Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes.

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2016-08-24
Last Posted Date
2019-04-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
55
Registration Number
NCT02877355
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2016-08-11
Last Posted Date
2022-07-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
711
Registration Number
NCT02863419
Locations
🇦🇪

Novo Nordisk Investigational Site, Umm Al Quwain, United Arab Emirates

Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2016-08-11
Last Posted Date
2022-07-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
822
Registration Number
NCT02863328
Locations
🇹🇭

Novo Nordisk Investigational Site, Bangkok, Thailand

Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus.

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
First Posted Date
2016-07-29
Last Posted Date
2022-07-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
504
Registration Number
NCT02849080
Locations
🇹🇷

Novo Nordisk Investigational Site, Rize, Turkey

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