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 Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes

First Posted Date
2019-04-16
Last Posted Date
2024-11-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
9642
Registration Number
NCT03914326
Locations
🇦🇷

Centro de Investigaciones Metabólicas, Capital Federal, Argentina

🇦🇷

Centro Diabetologico Cordoba Dr. Waitman, Cordoba, Argentina

🇦🇷

Centro médico privado Cemaic, Córdoba, Argentina

and more 458 locations

Triple Therapy in T1DM

First Posted Date
2019-04-02
Last Posted Date
2024-01-03
Lead Sponsor
State University of New York at Buffalo
Target Recruit Count
114
Registration Number
NCT03899402
Locations
🇺🇸

Diabetes and Endocrinology Research Center of WNY, Williamsville, New York, United States

Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)

First Posted Date
2019-03-21
Last Posted Date
2024-10-24
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
84
Registration Number
NCT03884075
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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

Completed
Conditions
Interventions
First Posted Date
2019-03-15
Last Posted Date
2021-01-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
215
Registration Number
NCT03876015
Locations
🇬🇧

Novo Nordisk Investigational Site, Wellingborough, United Kingdom

A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity

Phase 1
Completed
Conditions
Interventions
First Posted Date
2019-02-15
Last Posted Date
2020-12-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
72
Registration Number
NCT03842202
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

First Posted Date
2019-01-28
Last Posted Date
2024-08-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
3508
Registration Number
NCT03819153
Locations
🇺🇸

Alliance for Multispec Res, Norman, Oklahoma, United States

🇺🇸

Juno Research, LLC_Houston, Houston, Texas, United States

🇺🇸

Oceane 7 Medical & Research Center, Inc., Miami, Florida, United States

and more 402 locations

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-01-22
Last Posted Date
2024-11-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1500
Registration Number
NCT03811561
Locations
🇺🇸

Diabetes/Lipid Mgmt & Res Ctr, Huntington Beach, California, United States

🇸🇰

Nemocnica akademika L. Derera, UNB, Bratislava, Slovakia

🇺🇸

Del Sol Research Management, LLC, Tucson, Arizona, United States

and more 170 locations

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

First Posted Date
2019-01-22
Last Posted Date
2022-03-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
401
Registration Number
NCT03811574
Locations
🇰🇷

Novo Nordisk Investigational Site, Yangsan, Korea, Republic of

A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

First Posted Date
2018-12-28
Last Posted Date
2024-11-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
30
Registration Number
NCT03789578
Locations
🇩🇪

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

First Posted Date
2018-10-16
Last Posted Date
2019-09-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
88
Registration Number
NCT03707990
Locations
🇺🇸

Novo Nordisk Investigational Site, Tempe, Arizona, United States

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