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

Efficacy and Safety of Semaglutide Injection (HD1916) in Patients with Type 2 Diabetes Mellitus

Phase 3
Recruiting
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2023-12-08
Last Posted Date
2024-10-10
Lead Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Target Recruit Count
506
Registration Number
NCT06161844
Locations
🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangdong, Guangdong, China

Evaluation of Gastric Content of Volunteers Fasting and Using Semaglutide: an Observational and Cross-sectional Study

Completed
Conditions
Anesthesia
Pneumonia, Aspiration
Interventions
First Posted Date
2023-12-04
Last Posted Date
2023-12-04
Lead Sponsor
Hospital Israelita Albert Einstein
Target Recruit Count
30
Registration Number
NCT06154486
Locations
🇧🇷

Hospital Israelita Albert Einstein, Sao Paulo, Brazil

Subcutaneous Semaglutide in Systemic Scleroderma

Phase 1
Recruiting
Conditions
Scleroderma, Systemic
Fibrosis
Semaglutide
Interventions
First Posted Date
2023-11-28
Last Posted Date
2024-03-05
Lead Sponsor
Second Xiangya Hospital of Central South University
Target Recruit Count
10
Registration Number
NCT06149260
Locations
🇨🇳

the Second Xiangya Hospital, Changsha, Hunan, China

A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Phase 3
Active, not recruiting
Conditions
Obesity
Interventions
First Posted Date
2023-11-14
Last Posted Date
2025-05-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
809
Registration Number
NCT06131437
Locations
🇺🇸

Great Lakes Clinical Trials, Chicago, Illinois, United States

🇺🇸

Univ of Colorado at Denver, Aurora, Colorado, United States

🇺🇸

Northeast Research Institute, Fleming Island, Florida, United States

and more 42 locations

A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo

Phase 2
Active, not recruiting
Conditions
Chronic Kidney Disease
Type 2 Diabetes
Obesity
Interventions
First Posted Date
2023-11-14
Last Posted Date
2025-05-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
618
Registration Number
NCT06131372
Locations
🇸🇰

Univerzitna nemocnica L. Pasteura Kosice, Kosice, Slovakia

🇭🇺

Szent Margit Rendelőintézet Nonprofit Kft., Budapest, Hungary

🇭🇺

Békés Megyei Központi Kórház, Gyula, Hungary

and more 106 locations

Semaglutide Use in Acute Pulmonary Embolism

Completed
Conditions
Pulmonary Embolism
Interventions
First Posted Date
2023-11-07
Last Posted Date
2023-11-07
Lead Sponsor
Imperial College London
Target Recruit Count
18
Registration Number
NCT06118203
Locations
🇬🇧

Colm McCabe, London, United Kingdom

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2023-10-24
Last Posted Date
2024-07-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
121
Registration Number
NCT06097390
Locations
🇨🇦

Altasciences Clinical Company, Inc, Montreal, Quebec, Canada

Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes

Phase 3
Withdrawn
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2023-10-16
Last Posted Date
2024-02-26
Lead Sponsor
Novo Nordisk A/S
Registration Number
NCT06083675
Locations
🇹🇭

Songklanagarind Hospital, Songkla, Thailand

🇬🇷

General Hospital of Thessaloniki "G.Papanikolaou", Thessaloniki, Greece

🇵🇱

ETG Siedlce, Siedlce, Masovian, Poland

and more 97 locations

Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes

Phase 3
Recruiting
Conditions
Heart Failure
Cardiovascular Diseases
Type 1 Diabetes
Kidney Failure
Interventions
First Posted Date
2023-10-13
Last Posted Date
2025-01-10
Lead Sponsor
Steno Diabetes Center Copenhagen
Target Recruit Count
2000
Registration Number
NCT06082063
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

🇩🇰

Steno Diabetes Center Copenhagen, Herlev, Denmark

COMMETS- Combination MCI Metabolic Syndrome

Phase 2
Recruiting
Conditions
Alzheimer Disease
Mild Cognitive Impairment
Metabolic Syndrome
Interventions
Other: Semaglutide placebo
Other: Intranasal insulin placebo
First Posted Date
2023-10-10
Last Posted Date
2024-03-22
Lead Sponsor
Rutgers, The State University of New Jersey
Target Recruit Count
80
Registration Number
NCT06072963
Locations
🇮🇱

Joseph Sagol Neuroscience center, Sheba Medical Center, Ramat Gan, Israel

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