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 to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo (semaglutide)
First Posted Date
2019-01-28
Last Posted Date
2025-03-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
3533
Registration Number
NCT03819153
Locations
🇺🇸

Rocky Mount Reg VA Med-DN, Aurora, Colorado, United States

🇨🇦

Milestone Research, London, Ontario, Canada

🇨🇦

LMC Research Inc. Ottawa, Nepean, Ontario, Canada

and more 404 locations

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

Phase 3
Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo (semaglutide)
First Posted Date
2019-01-22
Last Posted Date
2025-04-29
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1500
Registration Number
NCT03811561
Locations
🇸🇰

MEDIVASA, s.r.o., Diabetologicka ambulancia, Zilina, Slovakia

🇪🇸

Hospital Vall d'Hebron, Barcelona, Spain

🇪🇸

Hospital de Bellvitge, Hospitalet de Llobregat, Spain

and more 171 locations

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

Phase 3
Completed
Conditions
Overweight
Obesity
Interventions
Drug: Placebo (semaglutide)
First Posted Date
2019-01-22
Last Posted Date
2022-03-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
401
Registration Number
NCT03811574
Locations
🇰🇷

Novo Nordisk Investigational Site, Yangsan, Korea, Republic of

A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2018-12-28
Last Posted Date
2024-11-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
30
Registration Number
NCT03789578
Locations
🇩🇪

Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

A Study Comparing the Dulaglutide Pen and the Semaglutide Pen

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2018-10-30
Last Posted Date
2020-04-24
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
312
Registration Number
NCT03724981
Locations
🇺🇸

Long Beach Center for Clinical Research, Long Beach, California, United States

🇺🇸

Palm Harbor Medical Associates, Palm Harbor, Florida, United States

🇺🇸

Georgia Clinical Research, Snellville, Georgia, United States

and more 11 locations

A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

Phase 1
Completed
Conditions
Obesity and Overweight
Interventions
Drug: NNC0165-1875
Drug: Placebo (NNC0165-1875)
First Posted Date
2018-10-16
Last Posted Date
2019-09-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
88
Registration Number
NCT03707990
Locations
🇺🇸

Novo Nordisk Investigational Site, Tempe, Arizona, United States

Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

Phase 3
Completed
Conditions
Obesity
Overweight
Interventions
Drug: Placebo (Semaglutide)
First Posted Date
2018-10-03
Last Posted Date
2023-07-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
304
Registration Number
NCT03693430
Locations
🇪🇸

Novo Nordisk Investigational Site, Sevilla, Spain

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Insulin glargine U100
First Posted Date
2018-09-28
Last Posted Date
2022-11-14
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
2274
Registration Number
NCT03689374
Locations
🇹🇷

Novo Nordisk Investigational Site, Trabzon, Turkey

GLP1R in Parkinson's Disease

Phase 2
Not yet recruiting
Conditions
Parkinson Disease
Interventions
First Posted Date
2018-09-06
Last Posted Date
2018-09-06
Lead Sponsor
Oslo University Hospital
Target Recruit Count
120
Registration Number
NCT03659682

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Denmark and Sweden, as Part of Local Clinical Practice (SURE DENMARK/SWEDEN)

Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2018-08-27
Last Posted Date
2021-11-15
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
333
Registration Number
NCT03648281
Locations
🇸🇪

Novo Nordisk Investigational Site, Örebro, Sweden

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