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 of Cotadutide in Participants Who Have Chronic Kidney Disease With Type 2 Diabetes Mellitus

First Posted Date
2020-08-17
Last Posted Date
2022-03-29
Lead Sponsor
AstraZeneca
Target Recruit Count
247
Registration Number
NCT04515849
Locations
🇬🇧

Research Site, London, United Kingdom

Post-Marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ozempic®

First Posted Date
2020-07-14
Last Posted Date
2023-11-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
3000
Registration Number
NCT04469855
Locations
🇯🇵

Novo Nordisk Investigational Site, Yokohama, Kanagawa, Japan

Semaglutide and Dapagliflozin in Diabetic Patients With Different Pathophysiology

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2020-06-30
Last Posted Date
2022-10-21
Lead Sponsor
Region Skane
Target Recruit Count
200
Registration Number
NCT04451837
Locations
🇸🇪

Anders Rosengrentest, Malmö, Skane, Sweden

16-week Flexible vs. 8-week Semaglutide Titration

First Posted Date
2020-06-25
Last Posted Date
2020-06-25
Lead Sponsor
Tel-Aviv Sourasky Medical Center
Target Recruit Count
100
Registration Number
NCT04447859
Locations
🇮🇱

Tel-Aviv Medical Center, Tel Aviv, Israel

Exercise and GLP-1 RA on Insulin Secretion

First Posted Date
2020-05-12
Last Posted Date
2021-02-11
Lead Sponsor
University of Copenhagen
Target Recruit Count
30
Registration Number
NCT04383197
Locations
🇩🇰

Xlab, Center for Healthy Aging, Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark

SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

Phase 3
Withdrawn
Conditions
Interventions
First Posted Date
2020-02-27
Last Posted Date
2022-02-03
Lead Sponsor
Novo Nordisk A/S
Registration Number
NCT04287179
Locations
🇸🇪

Novo Nordisk Investigational Site, Malmö, Sweden

The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity

First Posted Date
2020-02-10
Last Posted Date
2023-09-08
Lead Sponsor
University Medical Centre Ljubljana
Target Recruit Count
30
Registration Number
NCT04263415
Locations
🇸🇮

UMC Ljubljana, Ljubljana, Slovenia

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice (SURE GERMANY)

Completed
Conditions
Interventions
First Posted Date
2020-02-10
Last Posted Date
2023-03-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
789
Registration Number
NCT04261933
Locations
🇩🇪

Novo Nordisk Investigational Site, Zwenkau, Germany

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes

First Posted Date
2020-02-06
Last Posted Date
2023-11-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
152
Registration Number
NCT04259801
Locations
🇳🇱

Novo Nordisk Investigational Site, Groningen, Netherlands

Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.

First Posted Date
2020-01-31
Last Posted Date
2024-11-28
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
375
Registration Number
NCT04251156
Locations
🇰🇷

Novo Nordisk Investigational Site, Seoul, Korea, Republic of

🇧🇷

Instituto de Ciências Farmacêuticas de Estudos e Pesquisas, Aparecida de Goiania, Goias, Brazil

🇧🇷

CPCLIN - Centro de Pesquisas Clínicas, São Paulo, Sao Paulo, Brazil

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