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

GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab

Early Phase 1
Recruiting
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2024-03-29
Last Posted Date
2025-05-18
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
24
Registration Number
NCT06338553
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

Phase 3
Active, not recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-03-21
Last Posted Date
2025-04-22
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
180
Registration Number
NCT06323174
Locations
🇺🇸

Nat Res Inst Huntington Park, Huntington Park, California, United States

🇺🇸

Valley Clinical Trials, Inc., Northridge, California, United States

🇺🇸

Southern California Dermatology, Santa Ana, California, United States

and more 46 locations

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

Phase 3
Active, not recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-03-21
Last Posted Date
2025-05-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
270
Registration Number
NCT06323161
Locations
🇯🇵

Kumanomae Nishimura Internal Medical Clinic, Arakawa-ku, Tokyo, Japan

🇯🇵

Akaicho Clinic, Chiba-shi, Chiba, Japan

🇯🇵

Futata Tetsuhiro Clinic Meinohama, Fukuoka-shi, Fukuoka, Japan

and more 46 locations

The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes

Not Applicable
Recruiting
Conditions
Steroid-Induced Diabetes
Steroid Induced Hyperglycemia
Interventions
First Posted Date
2024-03-19
Last Posted Date
2024-10-02
Lead Sponsor
Imperial College London
Target Recruit Count
60
Registration Number
NCT06318442
Locations
🇬🇧

Imperial College Healthcare NHS Trust, London, United Kingdom

A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss

Phase 2
Recruiting
Conditions
Obesity
Interventions
Drug: Trevogrumab-Part B and Part C
Drug: Matching Placebo-Part A
Drug: Trevogrumab-Part A
Drug: Matching Placebo-Garetosmab
Drug: Matching Placebo-Trevogrumab
First Posted Date
2024-03-07
Last Posted Date
2025-05-11
Lead Sponsor
Regeneron Pharmaceuticals
Target Recruit Count
999
Registration Number
NCT06299098
Locations
🇺🇸

Pinnacle Research Group, Anniston, Alabama, United States

🇺🇸

Cullman Clinical Trials, Cullman, Alabama, United States

🇺🇸

Foothills Research Center Cct Research, Phoenix, Arizona, United States

and more 58 locations

A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight

Phase 1
Completed
Conditions
Obesity
Interventions
First Posted Date
2024-03-04
Last Posted Date
2025-05-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
34
Registration Number
NCT06289504
Locations
🇨🇦

Altasciences Company Inc., Mount-Royal, Quebec, Canada

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

Phase 4
Not yet recruiting
Conditions
Obesity, Morbid
Weight Gain
Obesity
Interventions
First Posted Date
2024-03-01
Last Posted Date
2024-03-01
Lead Sponsor
Zuyderland Medisch Centrum
Target Recruit Count
152
Registration Number
NCT06287307

Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt

Phase 2
Active, not recruiting
Conditions
Muscle Loss
Obesity
Interventions
First Posted Date
2024-02-28
Last Posted Date
2024-08-09
Lead Sponsor
Veru Inc.
Target Recruit Count
150
Registration Number
NCT06282458
Locations
🇺🇸

SKY Integrative Medical Center, Ridgeland, Mississippi, United States

🇺🇸

Artemis Institute for Clinical Research, San Diego, California, United States

🇺🇸

Palm Research Center, Las Vegas, Nevada, United States

and more 11 locations

Special Use - Results Surveillance on Long-term Use With Wegovy®

Conditions
Obesity
Interventions
First Posted Date
2024-02-28
Last Posted Date
2025-05-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
1000
Registration Number
NCT06283667
Locations
🇯🇵

Japanese Red Cross Hamamatsu Hospital_Cardiology, Shizuoka, Japan

🇯🇵

Osaki citizen hospital, Diabetes and metabolic disease, Osaki-shi, Miyagi, Japan

🇯🇵

The Jikei University Hospital Dept of Diabetes, Metabolic, Tokyo, Japan

and more 70 locations

SEMA-CardioDiab HUNGARY: A Research Study to Understand the Effects of Oral Semaglutide on Blood Sugar Levels, Weight, and Cardiovascular Risk in People With Type 2 Diabetes Patients in Hungary

Recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-02-21
Last Posted Date
2025-03-11
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
470
Registration Number
NCT06269120
Locations
🇭🇺

Siklósi Kórház, Diabetológia, Siklós, Hungary

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