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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

A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

Phase 2
Active, not recruiting
Conditions
Non-alcoholic Fatty Liver Disease
Fatty Liver, Nonalcoholic
NAFLD
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Interventions
First Posted Date
2023-05-26
Last Posted Date
2024-12-02
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
360
Registration Number
NCT05877547
Locations
🇺🇸

Indago Research & Health Center, Inc ( Site 3207), Hialeah, Florida, United States

🇺🇸

Sweet Hope Research Specialty, Inc-Research ( Site 3200), Hialeah, Florida, United States

🇺🇸

Velocity Clinical Research, Syracuse ( Site 3227), East Syracuse, New York, United States

and more 172 locations

Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

Phase 2
Not yet recruiting
Conditions
Endometrial Hyperplasia
Interventions
Drug: Placebo
Drug: Semaglutide
Drug: LNG-IUD (Progestin)
Behavioral: Telemedicine behavioral weight program
First Posted Date
2023-04-25
Last Posted Date
2024-12-27
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
96
Registration Number
NCT05829460
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Phase 3
Completed
Conditions
Overweight
Obesity
Interventions
First Posted Date
2023-04-21
Last Posted Date
2024-12-11
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
751
Registration Number
NCT05822830
Locations
🇺🇸

Southern California Dermatology, Inc., Santa Ana, California, United States

🇺🇸

University Clinical Investigators, Inc., Tustin, California, United States

🇺🇸

Weill Cornell Medical College, New York, New York, United States

and more 29 locations

Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

Phase 2
Recruiting
Conditions
Diabetic Kidney Disease
Type 1 Diabetes
Interventions
Other: Placebo
Drug: Semaglutide
First Posted Date
2023-04-21
Last Posted Date
2024-06-06
Lead Sponsor
University of Washington
Target Recruit Count
60
Registration Number
NCT05822609
Locations
🇺🇸

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

🇺🇸

University of Washington, Seattle, Washington, United States

🇨🇦

Toronto General Hospital, University Health Network, Toronto, Ontario, Canada

and more 1 locations

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Phase 3
Recruiting
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2023-04-19
Last Posted Date
2024-11-18
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
60
Registration Number
NCT05819138
Locations
🇺🇸

University of Washington Medicine Diabetes Institute (UWMDI), Seattle, Washington, United States

🇺🇸

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome

Phase 3
Recruiting
Conditions
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Obese
Interventions
First Posted Date
2023-04-19
Last Posted Date
2024-07-31
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
80
Registration Number
NCT05819853
Locations
🇺🇸

University of Colorado Anschutz/Children's Hospital Colorado Aurora, Aurora, Colorado, United States

A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes

Phase 3
Recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2023-04-14
Last Posted Date
2024-05-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
148
Registration Number
NCT05813912
Locations
🇲🇾

Hospital Universiti Kebangsaan Malaysia, Cheras, Kuala Lumpur, Malaysia

🇲🇾

Universiti Teknologi MARA, Sungai Buloh Campus, Sungai Buloh, Selangor, Malaysia

🇹🇭

King Chulalongkorn Memorial Hospital, Bangkok, Thailand

and more 28 locations

A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

Phase 3
Active, not recruiting
Conditions
Obesity or Overweight
Interventions
First Posted Date
2023-04-14
Last Posted Date
2024-12-09
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
330
Registration Number
NCT05813925
Locations
🇯🇵

Seino Internal Medicine Clinic, Koriyama-shi, Fukushima, Japan, Japan

🇯🇵

Tsuruma Kaneshiro Diabetes Clinic, Yamato-shi, Kanagawa, Japan

🇯🇵

Heiwadai Hospital, Miyazaki-shi, Miyazaki, Japan

and more 20 locations

Semaglutide in CFRD

Phase 2
Recruiting
Conditions
Cystic Fibrosis-related Diabetes
Cystic Fibrosis
Interventions
First Posted Date
2023-03-29
Last Posted Date
2024-06-28
Lead Sponsor
University of Minnesota
Target Recruit Count
15
Registration Number
NCT05788965
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus

Not Applicable
Recruiting
Conditions
Obesity, Abdominal
Diabetes Mellitus, Type 2
Abdominal Fat
Non-Alcoholic Fatty Liver Disease
Metformin
Metabolism Disorder, Glucose
Metabolism Disorder, Lipid
Interventions
First Posted Date
2023-03-22
Last Posted Date
2023-05-16
Lead Sponsor
RenJi Hospital
Target Recruit Count
300
Registration Number
NCT05779644
Locations
🇨🇳

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

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