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

Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

First Posted Date
2021-06-07
Last Posted Date
2024-10-09
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
617
Registration Number
NCT04916470
Locations
🇮🇳

Gandhi Memorial Hospital- King George's Medical University, Lucknow, Uttar Pradesh, India

🇮🇳

G B Pant Institute of Postgraduate Medical Education and Res, New Delhi, India

🇮🇳

Max Super Speciality Hospital_New Delhi, New Delhi, India

and more 111 locations

SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

Phase 3
Completed
Conditions
Interventions
First Posted Date
2021-05-17
Last Posted Date
2024-06-05
Lead Sponsor
University Medical Center Groningen
Target Recruit Count
125
Registration Number
NCT04889183
Locations
🇨🇦

University of Calgary, Calgary, Alberta, Canada

🇪🇸

Hospital Universitari de Bellvitge, Barcelona, Spain

🇳🇱

Isala, Zwolle, Overijssel, Netherlands

and more 10 locations

A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

First Posted Date
2021-05-07
Last Posted Date
2023-05-17
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
24
Registration Number
NCT04878406
Locations
🇯🇵

Novo Nordisk Investigational Site, Fukuoka, Japan

A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)

First Posted Date
2021-04-29
Last Posted Date
2024-06-25
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
105
Registration Number
NCT04865770
Locations
🇺🇸

Prolato Clinical Research Cntr, Houston, Texas, United States

🇺🇸

Academic Medical Research Institute, Los Angeles, California, United States

🇺🇸

N America Res Inst - San Dimas, San Dimas, California, United States

and more 28 locations

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-03-30
Last Posted Date
2024-12-04
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1200
Registration Number
NCT04822181
Locations
🇰🇷

Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of

🇰🇷

Chung-Ang University Hospital, Seoul, Korea, Republic of

🇲🇾

Hospital Selayang, Batu Caves, Malaysia

and more 430 locations

Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity

Phase 3
Completed
Conditions
Interventions
First Posted Date
2021-03-09
Last Posted Date
2024-06-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
529
Registration Number
NCT04788511
Locations
🇺🇸

John Hopkins Hospital, Baltimore, Maryland, United States

🇺🇸

Eastern Shore Rsrch Inst, LLC, Fairhope, Alabama, United States

🇺🇸

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

and more 87 locations

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-03-02
Last Posted Date
2024-10-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1840
Registration Number
NCT04777409
Locations
🇦🇺

HammondCare Greenwich, Greenwich, New South Wales, Australia

🇬🇧

NeuroClin, Motherwell, United Kingdom

🇺🇸

Banner Alzheimer's Institute, Phoenix, Arizona, United States

and more 378 locations

Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19

Phase 2
Conditions
Interventions
First Posted Date
2020-11-04
Last Posted Date
2022-02-08
Lead Sponsor
Vladimír Džavík
Target Recruit Count
400
Registration Number
NCT04615871
Locations
🇨🇦

St. Michael's Hospital, Toronto, Ontario, Canada

🇨🇦

University Health Network - Peter Munk Cardiac Centre, Toronto, Ontario, Canada

🇲🇽

Hospital de Infectologia, Mexico City, Mexico

and more 7 locations

A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes

First Posted Date
2020-09-23
Last Posted Date
2024-11-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
792
Registration Number
NCT04560998
Locations
🇦🇹

Universitätsklinik für Innere Medizin Graz, Graz, Austria

🇺🇸

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

🇩🇪

Herz- und Diabeteszentrum NRW - Bad Oeynhausen, Bad Oeynhausen, Germany

and more 120 locations

Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D

First Posted Date
2020-09-04
Last Posted Date
2024-07-29
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
60
Registration Number
NCT04538352
Locations
🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

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