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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

The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Obesity
Functional Hypogonadism
Interventions
First Posted Date
2024-07-08
Last Posted Date
2024-07-08
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
25
Registration Number
NCT06489457
Locations
🇸🇮

University Medical Centre Ljubljana, Ljubljana, Slovenia

A Research Study to Understand How People With Type 2 Diabetes Take Ozempic® and if the Ozempic®App Helps Them Stay on This Treatment

Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2024-06-27
Last Posted Date
2025-04-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
304
Registration Number
NCT06478550
Locations
🇬🇷

University Hospital of Athens ATTIKON, Athens, Attica, Greece

🇬🇷

General Hospital Of Thessaloniki Papageorgiou, Thessaloniki, Nea Efkarpia, Greece

🇬🇷

"Laiko" General Hospital of Athens, Goudi/Athens, Greece

and more 3 locations

Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus

Phase 4
Completed
Conditions
Psoriasis Vulgaris
Diabetes Type 2
Interventions
First Posted Date
2024-06-26
Last Posted Date
2024-07-01
Lead Sponsor
University of Banja Luka
Target Recruit Count
30
Registration Number
NCT06475586
Locations
🇧🇦

University of Banja Luka, Faculty of Medicine, Banja Luka, Bosnia and Herzegovina

The Effects of Semaglutide on Body Composition and Performance in Military Personnel

Phase 4
Not yet recruiting
Conditions
Obesity
Interventions
First Posted Date
2024-06-21
Last Posted Date
2024-06-21
Lead Sponsor
United States Army Research Institute of Environmental Medicine
Target Recruit Count
144
Registration Number
NCT06468748

Semaglutide in Auto-HSCT

Phase 2
Not yet recruiting
Conditions
Inflammation
Chemotherapeutic Toxicity
Intestinal Mucositis
Interventions
First Posted Date
2024-06-10
Last Posted Date
2024-06-10
Lead Sponsor
Klaus Gottlob Müller
Target Recruit Count
40
Registration Number
NCT06449625

Prevention of Progression of Prediabetes, Obesity and CV Risk

Phase 1
Recruiting
Conditions
Pre-Diabetes
Cardiovascular Diseases
Weight, Body
Interventions
First Posted Date
2024-06-06
Last Posted Date
2024-10-17
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
64
Registration Number
NCT06446531
Locations
🇺🇸

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese

Phase 2
Active, not recruiting
Conditions
Overweight and Obesity
Interventions
First Posted Date
2024-06-06
Last Posted Date
2024-10-03
Lead Sponsor
Scholar Rock, Inc.
Target Recruit Count
100
Registration Number
NCT06445075
Locations
🇺🇸

ProSciento CRU, Chula Vista, California, United States

🇺🇸

AdventHealth Translational Research Institute, Orlando, Florida, United States

🇺🇸

Great Lakes Clinical Trials, LLC d/b/a Flourish Research, Chicago, Illinois, United States

and more 4 locations

Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure

Phase 2
Recruiting
Conditions
Heart Failure With Reduced Ejection Fraction
Obesity
Weight Loss
Chronic Heart Failure
Interventions
Dietary Supplement: Calorie-restricted diet
First Posted Date
2024-05-21
Last Posted Date
2024-05-24
Lead Sponsor
Jens D Hove, MD,PHD
Target Recruit Count
100
Registration Number
NCT06423599
Locations
🇩🇰

Amager and Hvidovre Hospital University of Copenhagen, Copenhagen, Denmark

Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment

Phase 2
Recruiting
Conditions
Diabetes type1
Obesity
Interventions
First Posted Date
2024-05-13
Last Posted Date
2025-05-02
Lead Sponsor
Yale University
Target Recruit Count
54
Registration Number
NCT06411210
Locations
🇺🇸

Yale Pediatric Diabetes Center, Adult and Children's Progam, New Haven, Connecticut, United States

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