MedPath

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

Effect of Oral Semaglutide on Epicardial and Pericoronary Adipose Tissues in Type 2 Diabetes After Myocardial Infarction

Phase 4
Not yet recruiting
Conditions
Diabetic Patients
Acute Myocardial Infarction
Interventions
First Posted Date
2024-08-16
Last Posted Date
2024-08-26
Lead Sponsor
University of Sao Paulo General Hospital
Target Recruit Count
88
Registration Number
NCT06557811
Locations
🇧🇷

ARO (Academic Research Organization), São Paulo, SP, Brazil

GLP-1R Agonist Treatment for Opioid Use Disorder

Phase 2
Recruiting
Conditions
Opioid Abuse and Addiction
Narcotic-Related Disorders
Chemically-Induced Disorders
Opioid Use Disorder
Substance-Related Disorders
Mental Disorder
Opioid
Interventions
First Posted Date
2024-08-12
Last Posted Date
2025-03-28
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
200
Registration Number
NCT06548490
Locations
🇺🇸

University of Maryland Baltimore, Baltimore, Maryland, United States

🇺🇸

NYU Langone Health, New York, New York, United States

🇺🇸

Pennsylvania Psychiatric Institute, Harrisburg, Pennsylvania, United States

GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease

Not Applicable
Not yet recruiting
Conditions
Adiposity
Alcohol Use Disorder
Fatty Liver
Interventions
Behavioral: Weight reduction recommendations (nutritional and exercise)
First Posted Date
2024-08-09
Last Posted Date
2025-03-10
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
64
Registration Number
NCT06546384
Locations
🇨🇭

University Hospital Bern, Bern, Switzerland

Mechanisms of Semaglutide Therapy in Heart Failure Patients

Phase 1
Recruiting
Conditions
Heart Failure
Obesity
Interventions
First Posted Date
2024-08-07
Last Posted Date
2024-08-07
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
10
Registration Number
NCT06541509
Locations
🇸🇮

University Medical Center Ljubljana, Ljubljana, Slovenia

🇺🇸

Greenstone Biosciences, Palo Alto, California, United States

🇺🇸

Stanford Cardiovascular Institute, Stanford, California, United States

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

Phase 3
Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2024-08-02
Last Posted Date
2025-04-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1023
Registration Number
NCT06534411
Locations
🇺🇸

South Broward Research LLC, Miramar, Florida, United States

🇺🇸

West Orange Endocrinology, Ocoee, Florida, United States

🇺🇸

Optimal Research Sites, Orange City, Florida, United States

and more 141 locations

Holding vs. Continuing Incretin-based Therapies Before Upper Endoscopy

Not Applicable
Recruiting
Conditions
Diabetes Mellitus, Type 2
Obesity
Gastroparesis
Interventions
First Posted Date
2024-08-01
Last Posted Date
2025-02-19
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
120
Registration Number
NCT06533527
Locations
🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

Real World Effectiveness of Oral Semaglutide in Thailand Participants With Type 2 Diabetes

Not yet recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2024-07-18
Last Posted Date
2024-07-18
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
209
Registration Number
NCT06507475

A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a GLP-1 Agonist

Phase 2
Active, not recruiting
Conditions
Overweight and Obesity
Healthy
Interventions
First Posted Date
2024-07-15
Last Posted Date
2024-08-12
Lead Sponsor
Neurogastrx, Inc.
Target Recruit Count
120
Registration Number
NCT06500429
Locations
🇺🇸

Celerion, Tempe, Arizona, United States

Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation

Phase 3
Not yet recruiting
Conditions
Overweight or Obesity
Atrial Fibrillation
Interventions
Drug: Placebo
First Posted Date
2024-07-15
Last Posted Date
2025-05-11
Lead Sponsor
University of Chicago
Target Recruit Count
200
Registration Number
NCT06499857
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

The University of Arizona College of Medicine- Phoenix, Phoenix, Arizona, United States

Open Randomized Study of Comparative Pharmacokinetics and Biosimilarity of GP40221 (GEROPHARM LLC, Russia) and Ozempic®.

Phase 1
Completed
Conditions
Pharmacokinetics
Safety Issues
Bioequivalence
Interventions
First Posted Date
2024-07-11
Last Posted Date
2024-07-11
Lead Sponsor
Geropharm
Target Recruit Count
120
Registration Number
NCT06497049
Locations
🇷🇺

Yarosslavl Clinical Hospital #3, Yaroslavl, Russian Federation

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