MedPath

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 Probenecid and Ciclosporin on the Concentrations of SNAC in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2018-03-15
Last Posted Date
2019-06-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
21
Registration Number
NCT03466567
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Canada, as Part of Local Clinical Practice

Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2018-03-07
Last Posted Date
2021-09-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
462
Registration Number
NCT03457012
Locations
🇨🇦

Novo Nordisk Investigational Site, Cambridge, Ontario, Canada

A Study on How Semaglutide Works on Early Stages of Scar Tissue in the Liver Assessed by Pictures of the Liver

Phase 1
Completed
Conditions
Hepatobiliary Disorders
Non-alcoholic Fatty Liver Disease
Interventions
Drug: Placebo
First Posted Date
2017-11-29
Last Posted Date
2021-11-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
67
Registration Number
NCT03357380
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

Once Weekly GLP-1 in Persons With Spinal Cord Injury

Phase 4
Completed
Conditions
Spinal Cord Injuries
Pre Diabetes
Insulin Resistance
Obesity
Interventions
First Posted Date
2017-09-25
Last Posted Date
2023-03-14
Lead Sponsor
James J. Peters Veterans Affairs Medical Center
Target Recruit Count
5
Registration Number
NCT03292315
Locations
🇺🇸

Kessler Institute for Rehabilitation, West Orange, New Jersey, United States

A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
Drug: Placebo (semaglutide 1.0 mg)
Drug: Placebo (semaglutide 0.5 mg)
First Posted Date
2017-09-20
Last Posted Date
2021-02-15
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
36
Registration Number
NCT03288740
Locations
🇨🇳

Novo Nordisk Investigational Site, Beijing, China

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2017-06-19
Last Posted Date
2019-10-15
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
577
Registration Number
NCT03191396
Locations
🇬🇧

Novo Nordisk Investigational Site, Watford, United Kingdom

Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Healthy
Interventions
Drug: Placebo
First Posted Date
2017-05-08
Last Posted Date
2017-05-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
58
Registration Number
NCT03144271
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

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

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo (canagliflozin)
Drug: Placebo (semaglutide)
First Posted Date
2017-05-02
Last Posted Date
2020-01-21
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
788
Registration Number
NCT03136484
Locations
🇬🇧

Novo Nordisk Investigational Site, Wellingborough, United Kingdom

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
Interventions
Drug: Placebo
First Posted Date
2017-03-22
Last Posted Date
2021-07-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
302
Registration Number
NCT03086330
Locations
🇷🇺

Novo Nordisk Investigational Site, St. Petersburg, Russian Federation

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

First Posted Date
2017-02-23
Last Posted Date
2021-03-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
868
Registration Number
NCT03061214
Locations
🇺🇦

Novo Nordisk Investigational Site, Lviv, Ukraine

© Copyright 2025. All Rights Reserved by MedPath