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 Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus

Phase 1
Not yet recruiting
Conditions
Diabetes Mellitus
Insulin Sensitivity
Interventions
First Posted Date
2025-05-21
Last Posted Date
2025-05-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
95
Registration Number
NCT06982859
Locations
🇩🇪

Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, Germany

Comparative Effectiveness of Tirzepatide vs Semaglutide in Participants With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction

Active, not recruiting
Conditions
Type 2 Diabetes
Heart Failure
Interventions
First Posted Date
2025-05-20
Last Posted Date
2025-05-20
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
26000
Registration Number
NCT06980623
Locations
🇺🇸

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

Promoting Healthy Children and Youth

Phase 4
Not yet recruiting
Conditions
Obesity, Childhood
Interventions
First Posted Date
2025-05-18
Last Posted Date
2025-05-18
Lead Sponsor
University of Minnesota
Target Recruit Count
1020
Registration Number
NCT06977438

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

Phase 2
Not yet recruiting
Conditions
Menopause
Menopause Hot Flashes
Menopause Related Conditions
Cardiovascular
Interventions
Behavioral: Life style intervention
Drug: Anti-hypertensives
Drug: Hormonal therapy
Drug: Lipid Lowering Medication
First Posted Date
2025-05-16
Last Posted Date
2025-05-16
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
200
Registration Number
NCT06975111
Locations
🇺🇸

University of Colorado-School of Medicine, Aurora, Colorado, United States

Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study)

Phase 4
Conditions
Diabetes Mellitus
Cardiovascular Diseases
Cerebrovascular Disease
Interventions
First Posted Date
2025-05-07
Last Posted Date
2025-05-07
Lead Sponsor
China-Japan Friendship Hospital
Target Recruit Count
142
Registration Number
NCT06959784
Locations
🇨🇳

China-Japan Friendship hospital, Beijing, China

Effect of Semaglutide in Patients With Psoriasis and Obesity

Phase 3
Recruiting
Conditions
Psoriasis (PsO)
Obesity and Overweight
Interventions
First Posted Date
2025-04-20
Last Posted Date
2025-05-13
Lead Sponsor
The University of Hong Kong
Target Recruit Count
14
Registration Number
NCT06937060
Locations
🇭🇰

The University of Hong Kong, Department of Medicine, Hong Kong, Hong Kong

Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

Phase 3
Not yet recruiting
Conditions
Pediatric Obesity
Metabolic and Bariatric Surgery
Semaglutide
Interventions
First Posted Date
2025-04-18
Last Posted Date
2025-04-18
Lead Sponsor
Children's Hospital Los Angeles
Target Recruit Count
150
Registration Number
NCT06934655
Locations
🇺🇸

Children's Hospital Los Angeles, Los Angeles, California, United States

Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus

Phase 2
Not yet recruiting
Conditions
Kidney Transplant Recipient
Interventions
First Posted Date
2025-04-06
Last Posted Date
2025-04-06
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
74
Registration Number
NCT06913023
Locations
🇨🇦

St. Paul's Hospital, Vancouver, British Columbia, Canada

🇨🇦

Toronto General Hospital, Toronto, Ontario, Canada

Comparative Effectiveness of Tirzepatide Versus Semaglutide in Individuals With Heart Failure With Preserved Ejection Fraction

Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
HFpEF - Heart Failure With Preserved Ejection Fraction
Interventions
First Posted Date
2025-04-06
Last Posted Date
2025-04-17
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
28118
Registration Number
NCT06914141
Locations
🇺🇸

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

Emulation of the STEP-HFpEF DM Heart Failure Trial in Healthcare Claims Data

Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
HFpEF - Heart Failure With Preserved Ejection Fraction
Interventions
Drug: Placebo
First Posted Date
2025-04-06
Last Posted Date
2025-04-17
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
58387
Registration Number
NCT06914102
Locations
🇺🇸

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

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