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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 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

A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: SNAC
Drug: Microgynon®
First Posted Date
2016-07-27
Last Posted Date
2017-06-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
25
Registration Number
NCT02845219
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: placebo
First Posted Date
2016-07-11
Last Posted Date
2020-02-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
324
Registration Number
NCT02827708
Locations
🇬🇧

Novo Nordisk Investigational Site, Wellingborough, United Kingdom

A Trial Investigating the Effect of Oral Semaglutide Compared With Placebo on Postprandial Glucose and Triglyceride Metabolism, Energy Intake, Appetite Sensations and Gastric Emptying in Subjects With Type 2 Diabetes

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: placebo
First Posted Date
2016-05-16
Last Posted Date
2020-12-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
15
Registration Number
NCT02773381
Locations
🇬🇧

Novo Nordisk Investigational Site, Leeds, United Kingdom

A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
Drug: placebo
First Posted Date
2016-02-26
Last Posted Date
2022-07-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
3183
Registration Number
NCT02692716
Locations
🇬🇧

Novo Nordisk Investigational Site, Watford, United Kingdom

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2016-01-06
Last Posted Date
2019-10-15
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1201
Registration Number
NCT02648204
Locations
🇬🇧

Novo Nordisk Investigational Site, Watford, United Kingdom

Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2015-11-18
Last Posted Date
2022-07-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1864
Registration Number
NCT02607865
Locations
🇬🇧

Novo Nordisk Investigational Site, Wellingborough, United Kingdom

Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
Drug: placebo
First Posted Date
2015-09-23
Last Posted Date
2017-01-04
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
113
Registration Number
NCT02557620
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2015-06-03
Last Posted Date
2019-07-31
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
706
Registration Number
NCT02461589
Locations
🇬🇧

Novo Nordisk Investigational Site, Truro, United Kingdom

Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

Phase 2
Completed
Conditions
Metabolism and Nutrition Disorder
Obesity
Interventions
First Posted Date
2015-05-25
Last Posted Date
2020-04-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
957
Registration Number
NCT02453711
Locations
🇬🇧

Novo Nordisk Investigational Site, Rotherham, United Kingdom

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