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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

A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: placebo
Drug: semaglutide
First Posted Date
2014-05-26
Last Posted Date
2018-08-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
38
Registration Number
NCT02147431
Locations
🇦🇹

Novo Nordisk Investigational Site, Graz, Austria

A Trial to Assess the Pharmacokinetics, Pharmacodynamics, and the Safety and Tolerability of Semaglutide in Healthy Male Japanese and Caucasian Subjects

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Healthy
Interventions
Drug: placebo
Drug: semaglutide
First Posted Date
2014-05-23
Last Posted Date
2018-04-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
44
Registration Number
NCT02146079
Locations
🇯🇵

Novo Nordisk Investigational Site, Tokyo, Japan

Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2014-05-01
Last Posted Date
2019-06-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1089
Registration Number
NCT02128932
Locations
🇬🇧

Novo Nordisk Investigational Site, Taunton, United Kingdom

Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo

Phase 1
Completed
Conditions
Diabetes
Obesity
Metabolism and Nutrition Disorder
Interventions
Drug: placebo
Drug: semaglutide
First Posted Date
2014-03-06
Last Posted Date
2017-12-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
30
Registration Number
NCT02079870
Locations
🇬🇧

Novo Nordisk Investigational Site, Leeds, United Kingdom

A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
First Posted Date
2014-02-25
Last Posted Date
2020-02-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
52
Registration Number
NCT02070510
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
First Posted Date
2014-02-17
Last Posted Date
2018-06-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
168
Registration Number
NCT02064348
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
First Posted Date
2014-02-12
Last Posted Date
2017-03-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
7
Registration Number
NCT02060266
Locations
🇳🇱

Novo Nordisk Investigational Site, Groningen, Netherlands

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: semaglutide
Drug: placebo
First Posted Date
2014-02-04
Last Posted Date
2019-06-12
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
388
Registration Number
NCT02054897
Locations
🇬🇧

Novo Nordisk Investigational Site, Swansea, United Kingdom

Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2013-12-27
Last Posted Date
2017-04-04
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
24
Registration Number
NCT02022254
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Healthy
Interventions
First Posted Date
2013-12-20
Last Posted Date
2018-05-15
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
56
Registration Number
NCT02016911
Locations
🇸🇰

Novo Nordisk Investigational Site, Bratislava, Slovakia

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