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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 Phase III Study Comparing the Weight Loss Effects of Semaglutide Injection and Wegovy®

Phase 3
Not yet recruiting
Conditions
Obesity
Interventions
First Posted Date
2024-10-09
Last Posted Date
2024-10-09
Lead Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Target Recruit Count
370
Registration Number
NCT06633783
Locations
🇨🇳

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China

🇨🇳

Xuancheng People's Hospital, Xuancheng, Anhui, China

🇨🇳

Huizhou Central People's Hospital, Huizhou, Guangdong, China

and more 11 locations

Semaglutide and Intestinal Iron Absorption

Not Applicable
Completed
Conditions
Diabetes Mellitus Type 2
Iron Absorption
Interventions
First Posted Date
2024-10-08
Last Posted Date
2024-12-05
Lead Sponsor
University Hospital Dubrava
Target Recruit Count
51
Registration Number
NCT06629688
Locations
🇭🇷

University hospital Dubrava, Zagreb, Croatia

Tailoring Obesity Treatment Trial

Phase 2
Suspended
Conditions
Obesity
Appetite Regulation
PreDiabetes
Interventions
First Posted Date
2024-10-01
Last Posted Date
2025-02-28
Lead Sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
Target Recruit Count
40
Registration Number
NCT06619015
Locations
🇩🇰

University hospital of Southern Denmark, Esbjerg, Denmark

Efficacy and Safety of Semaglutide for Weight Loss in Overweight or Obese Adults in Bangladesh With or Without Type 2 Diabetes Mellitus

Phase 3
Not yet recruiting
Conditions
Obesity
Type 2 Diabetes Mellitus (T2DM)
Interventions
First Posted Date
2024-09-27
Last Posted Date
2024-09-27
Lead Sponsor
Popular Medical College Hospital
Target Recruit Count
480
Registration Number
NCT06616961
Locations
🇧🇩

Popular Medical College Hospital, Dhaka, Bangladesh

Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes

Phase 4
Recruiting
Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
First Posted Date
2024-09-26
Last Posted Date
2024-10-17
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
90
Registration Number
NCT06613854
Locations
🇸🇮

University Medical Centre Ljubljana, Diabetes Outpatient Clinic, Ljubljana, Slovenia

Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function

Not Applicable
Recruiting
Conditions
HPA
Adrenal Insufficiency
Healthy Volunteer Study
Cortisol Deficiency
Interventions
Drug: Placebo
First Posted Date
2024-09-23
Last Posted Date
2025-02-11
Lead Sponsor
University Hospital, Basel, Switzerland
Target Recruit Count
23
Registration Number
NCT06608433
Locations
🇨🇭

University Hospital Basel, Basel, Switzerland

Semaglutide in Treatment of Obesity

Phase 3
Active, not recruiting
Conditions
Weight Management
Interventions
First Posted Date
2024-09-19
Last Posted Date
2024-11-12
Lead Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Target Recruit Count
462
Registration Number
NCT06604624
Locations
🇨🇳

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

Efficacy, Safety, and Tolerability of Once Daily Oral Administration of AZD5004 Versus Placebo for 26 Weeks in Adults With Type 2 Diabetes Mellitus.

Phase 2
Recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo (placebo matching AZD5004 film-coated tablet)
First Posted Date
2024-08-30
Last Posted Date
2025-04-27
Lead Sponsor
AstraZeneca
Target Recruit Count
384
Registration Number
NCT06579105
Locations
🇬🇧

Research Site, Yate, United Kingdom

Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents

Phase 1
Recruiting
Conditions
Obesity
Adolescent Obesity
Body-Weight Trajectory
Weight Loss Trajectory
Bariatric Surgery
Anti-obesity Agents
Interventions
Behavioral: Standard postoperative care
First Posted Date
2024-08-28
Last Posted Date
2025-02-27
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
48
Registration Number
NCT06575738
Locations
🇺🇸

Childrens Hospital Colorado, Aurora, Colorado, United States

STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss

Phase 4
Recruiting
Conditions
Obesity
Interventions
First Posted Date
2024-08-26
Last Posted Date
2025-05-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
500
Registration Number
NCT06571383
Locations
🇺🇸

Neighborhood Healthcare, Escondido, California, United States

🇺🇸

Clinical Neuroscience Solution, Orlando, Florida, United States

🇺🇸

TMH Physician Partners Endo, Tallahassee, Florida, United States

and more 87 locations
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