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

Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy

Phase 4
Not yet recruiting
Conditions
Prostate Cancer
Interventions
First Posted Date
2025-04-03
Last Posted Date
2025-04-03
Lead Sponsor
Hamilton Health Sciences Corporation
Target Recruit Count
20
Registration Number
NCT06908694
Locations
🇨🇦

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Semaglutide Treatment in Type 1 Diabetes

Phase 3
Not yet recruiting
Conditions
Obesity in Diabetes
Obesity/therapy
Type 1 Diabetes Mellitus (T1DM)
Insulin Sensitivity/Resistance
Semaglutide
Lipidomics
Metabolomics
Weight Loss
Glycemic Control for Diabetes Mellitus
Interventions
First Posted Date
2025-04-03
Last Posted Date
2025-04-03
Lead Sponsor
Nordsjaellands Hospital
Target Recruit Count
122
Registration Number
NCT06909006
Locations
🇩🇰

Nordsjaellands Hospital, Hillerød, Denmark

A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)

Phase 3
Recruiting
Conditions
Overweight
Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
Interventions
First Posted Date
2025-03-19
Last Posted Date
2025-05-14
Lead Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Target Recruit Count
470
Registration Number
NCT06884293
Locations
🇨🇳

Beijing Hospital, Beijing, Beijing, China

PEG-rhGH and Semaglutide Combination Therapy in Non-Diabetic Obese Adults

Phase 4
Not yet recruiting
Conditions
Non-diabetic Obesity
Interventions
Drug: PEG-rhGH Injection + Semaglutide Injection
First Posted Date
2025-03-07
Last Posted Date
2025-03-07
Lead Sponsor
Shanghai Zhongshan Hospital
Target Recruit Count
212
Registration Number
NCT06863363
Locations
🇨🇳

Zhongshan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China

JOULE - Metabolic Adaptation to Weight Loss in Response to a Behavioural Lifestyle Program With or Without Semaglutide in Adolescents With Obesity

Phase 4
Not yet recruiting
Conditions
Obesity (Disorder)
Interventions
Behavioral: Behavioural Lifestyle Program (BLP)
First Posted Date
2025-02-28
Last Posted Date
2025-03-24
Lead Sponsor
McMaster University
Target Recruit Count
74
Registration Number
NCT06852391
Locations
🇨🇦

McMaster University, Hamilton, Ontario, Canada

Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes Clinical Trial

First Posted Date
2025-02-28
Last Posted Date
2025-03-04
Lead Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Target Recruit Count
504
Registration Number
NCT06851962
Locations
🇪🇸

Hospital Universitario Regional de Málaga, Málaga, Spain

🇪🇸

Hospital Clínico Universitario de Valencia, Valencia, Spain

🇪🇸

Hospital General Universitario de Valencia (HGUV), Valencia, Spain

and more 1 locations

The Safety, Tolerability, and Pharmacokinetics of of SYH9017 in Chinese Participants With Overweight and Obesity

Phase 1
Recruiting
Conditions
Overweight or Obesity
Interventions
Drug: Placebo
Drug: Wegovy ®
First Posted Date
2025-02-17
Last Posted Date
2025-03-06
Lead Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Target Recruit Count
66
Registration Number
NCT06830343
Locations
🇨🇳

Peking University Third Hospital, Beijing, Beijing, China

A Study of a Novel Precision Medicine Approach for Obesity

Phase 4
Recruiting
Conditions
Obesity
Interventions
Drug: Placebo
First Posted Date
2025-02-07
Last Posted Date
2025-02-25
Lead Sponsor
Mayo Clinic
Target Recruit Count
135
Registration Number
NCT06814938
Locations
🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Bariatric Surgery vs. Semaglutide vs. Tirzepatide

Phase 4
Recruiting
Conditions
Obesity and Obesity-related Medical Conditions
Interventions
Procedure: Bariatric Surgery
First Posted Date
2025-01-31
Last Posted Date
2025-04-17
Lead Sponsor
Ali Aminian
Target Recruit Count
125
Registration Number
NCT06803888
Locations
🇺🇸

The Cleveland Clinic, Cleveland, Ohio, United States

Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions

Phase 4
Not yet recruiting
Conditions
Obesity
Interventions
First Posted Date
2025-01-30
Last Posted Date
2025-02-04
Lead Sponsor
Mayo Clinic
Target Recruit Count
30
Registration Number
NCT06801015
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

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