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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

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: placebo
First Posted Date
2014-12-02
Last Posted Date
2019-06-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
397
Registration Number
NCT02305381
Locations
🇸🇰

Novo Nordisk Investigational Site, Presov, Slovakia

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily in Japanese Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2014-10-01
Last Posted Date
2018-09-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
308
Registration Number
NCT02254291
Locations
🇯🇵

Novo Nordisk Investigational Site, Yokohama-shi, Japan

Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
First Posted Date
2014-09-26
Last Posted Date
2018-08-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
54
Registration Number
NCT02249871
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
First Posted Date
2014-09-26
Last Posted Date
2020-02-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
32
Registration Number
NCT02249910
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
First Posted Date
2014-09-17
Last Posted Date
2017-04-04
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
31
Registration Number
NCT02243098
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
First Posted Date
2014-09-04
Last Posted Date
2015-01-26
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
42
Registration Number
NCT02231684

A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: placebo
First Posted Date
2014-08-08
Last Posted Date
2018-03-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
87
Registration Number
NCT02212067
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Phase 1
Completed
Conditions
Hepatic Impaired
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2014-08-07
Last Posted Date
2017-12-21
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
44
Registration Number
NCT02210871
Locations
🇸🇰

Novo Nordisk Investigational Site, Bratislava, Slovakia

A Trial Comparing the Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: DPP-4 inhibitor
First Posted Date
2014-08-04
Last Posted Date
2019-01-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
601
Registration Number
NCT02207374
Locations
🇯🇵

Novo Nordisk Investigational Site, Yokohama-shi, Japan

Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
First Posted Date
2014-06-24
Last Posted Date
2014-10-21
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
78
Registration Number
NCT02172313
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