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

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Phase 2
Recruiting
Conditions
Chronic Kidney Disease
Interventions
First Posted Date
2024-12-05
Last Posted Date
2025-04-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
465
Registration Number
NCT06717698
Locations
🇯🇵

Kato Clinic of Internal Medicine, Tokyo, Japan

🇰🇷

Pusan National University Hospital, Busan, Korea, Republic of

🇰🇷

National Health Insurance Corporation Ilsan Hospital, Goyang, Korea, Republic of

and more 114 locations

A Study of BGM0504 in Participants with Type 2 Diabetes

Phase 3
Recruiting
Conditions
Type 2 Diabetes Mellitus (T2DM)
First Posted Date
2024-12-04
Last Posted Date
2025-02-07
Lead Sponsor
BrightGene Bio-Medical Technology Co., Ltd.
Target Recruit Count
537
Registration Number
NCT06716216
Locations
🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes

Phase 4
Recruiting
Conditions
Spinal Cord Injuries
Type 2 Diabetes
Interventions
First Posted Date
2024-11-26
Last Posted Date
2025-04-17
Lead Sponsor
Marzieh Salehi
Target Recruit Count
50
Registration Number
NCT06706284
Locations
🇺🇸

University Health - Texas Diabetic Institute, San Antonio, Texas, United States

🇺🇸

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

A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2024-11-21
Last Posted Date
2024-11-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
38
Registration Number
NCT06699329
Locations
🇺🇸

Celerion (Site 0001), Lincoln, Nebraska, United States

Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV

Phase 2
Not yet recruiting
Conditions
Cocaine Use Disorder
HIV
Interventions
Drug: Placebo
First Posted Date
2024-11-15
Last Posted Date
2025-04-23
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
40
Registration Number
NCT06691243

Emulation of the SOUL Diabetes Trial in Healthcare Claims

Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2024-10-26
Last Posted Date
2024-12-20
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
43650
Registration Number
NCT06659718
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

Phase 3
Recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-10-18
Last Posted Date
2024-12-02
Lead Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Target Recruit Count
840
Registration Number
NCT06649344
Locations
🇨🇳

Zhu Xianyi Memorial Hospital,Tianjin Medical University, Tianjin, Tianjin, China

Semaglutide for Helping Opioid Recovery

Phase 2
Not yet recruiting
Conditions
Opioid Use Disorder
Interventions
Other: Placebo
First Posted Date
2024-10-15
Last Posted Date
2025-02-05
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
46
Registration Number
NCT06639464
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

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

Phase 1
Recruiting
Conditions
Healthy Volunteers Type 2 Diabetes
Interventions
First Posted Date
2024-10-15
Last Posted Date
2024-11-21
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
90
Registration Number
NCT06642584
Locations
🇨🇦

Altasciences, Montreal, Quebec, Canada

Pharmacokinetic Similarity, Safety, and Immunogenicity of Semaglutide Injection and Ozempic ® Injection in Healthy Subjects.

Phase 1
Recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-10-10
Last Posted Date
2024-10-10
Lead Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Target Recruit Count
68
Registration Number
NCT06634927
Locations
🇨🇳

The Second Hospital of Anhui Medical University, Hefei, Anhui, China

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