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

Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

First Posted Date
2018-10-03
Last Posted Date
2023-07-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
304
Registration Number
NCT03693430
Locations
🇪🇸

Novo Nordisk Investigational Site, Sevilla, Spain

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

First Posted Date
2018-09-28
Last Posted Date
2022-11-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
2274
Registration Number
NCT03689374
Locations
🇹🇷

Novo Nordisk Investigational Site, Trabzon, Turkey

GLP1R in Parkinson's Disease

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2018-09-06
Last Posted Date
2018-09-06
Lead Sponsor
Oslo University Hospital
Target Recruit Count
120
Registration Number
NCT03659682

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Denmark and Sweden, as Part of Local Clinical Practice (SURE DENMARK/SWEDEN)

Completed
Conditions
Interventions
First Posted Date
2018-08-27
Last Posted Date
2021-11-15
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
333
Registration Number
NCT03648281
Locations
🇸🇪

Novo Nordisk Investigational Site, Örebro, Sweden

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Switzerland, as Part of Local Clinical Practice (SURE SWITZERLAND)

Completed
Conditions
Interventions
First Posted Date
2018-08-15
Last Posted Date
2021-07-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
215
Registration Number
NCT03631186
Locations
🇨🇭

Novo Nordisk Investigational Site, Zürich, Switzerland

Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program

First Posted Date
2018-08-02
Last Posted Date
2021-11-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
611
Registration Number
NCT03611582
Locations
🇺🇸

Novo Nordisk Investigational Site, Olympia, Washington, United States

A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

First Posted Date
2018-07-26
Last Posted Date
2021-11-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
96
Registration Number
NCT03600480
Locations
🇺🇸

Novo Nordisk Investigational Site, Overland Park, Kansas, United States

Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial

First Posted Date
2018-07-23
Last Posted Date
2024-07-03
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1278
Registration Number
NCT03596450
Locations
🇺🇸

Primary Care Research, Atlanta, Georgia, United States

🇺🇸

Palm Research Center Inc-Vegas, Las Vegas, Nevada, United States

🇺🇸

SC Clinical Research, Inc., Garden Grove, California, United States

and more 118 locations

Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

First Posted Date
2018-07-02
Last Posted Date
2024-06-03
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
17609
Registration Number
NCT03574597
Locations
🇺🇸

Mercy Hospital and Medical Center, Chicago, Illinois, United States

🇺🇸

Preferred Primary Care Physicians Inc., Pittsburgh, Pennsylvania, United States

🇺🇸

Angel City Research, Inc., Los Angeles, California, United States

and more 827 locations

A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese

First Posted Date
2018-07-02
Last Posted Date
2021-07-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
37
Registration Number
NCT03574584
Locations
🇺🇸

Novo Nordisk Investigational Site, Lincoln, Nebraska, United States

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