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Last Updated: October 24, 2020

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CLINICAL TRIALS PROFILE FOR SEMAGLUTIDE

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505(b)(2) Clinical Trials for Semaglutide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT03638778 Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men Recruiting Novo Nordisk A/S Phase 1 2018-08-17 This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.
New Formulation NCT04097600 A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Not yet recruiting Novo Nordisk A/S Phase 1 2019-09-30 In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. One is the current formulation and the other one is a new formulation of semaglutide. Both will be administered as a tablet and are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. The tablet version of the study medicine is a new medicine that cannot yet be prescribed. Participants will either get semaglutide in the current tablet formulation previously tested in many large studies, or get the tablet that contains semaglutide in a new formulation - which treatment is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment in a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, participants must take their breakfast 30-45 minutes after dosing.
New Formulation NCT04109508 A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets Not yet recruiting Novo Nordisk A/S Phase 1 2019-10-02 In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. Besides semaglutide, the current version of the tablet contains 300 mg SNAC and 3 helping agents, while the new version of the tablet contains 300 mg SNAC and only one helping agent. Both are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. Semaglutide cannot yet be prescribed as a tablet. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. Participants will get semaglutide in the current tablet formulation and in a new formulation - in which order they receive the two different formulations is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment for a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, they must take their breakfast 30-45 minutes after dosing.
New Dosage NCT04287179 SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes Not yet recruiting Novo Nordisk A/S Phase 3 2020-03-09 This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Semaglutide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00696657 A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide Completed Novo Nordisk A/S Phase 2 2008-06-01 This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.
NCT00813020 A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects Completed Novo Nordisk A/S Phase 1 2009-01-01 This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.
NCT00833716 Effect of Renal Impairment on the Pharmacokinetics of NN9535 Completed Novo Nordisk A/S Phase 1 2009-02-01 This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate how different degrees of renal impairment (mild, moderate, severe and end-stage renal disease) affect the pharmacokinetics of NN9535.
NCT00851773 Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects Completed Novo Nordisk A/S Phase 1 2009-02-01 This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Semaglutide

Condition Name

Condition Name for Semaglutide
Intervention Trials
Diabetes Mellitus, Type 2 72
Diabetes 61
Healthy 24
Obesity 20
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Condition MeSH

Condition MeSH for Semaglutide
Intervention Trials
Diabetes Mellitus, Type 2 80
Diabetes Mellitus 72
Overweight 22
Obesity 18
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Clinical Trial Locations for Semaglutide

Trials by Country

Trials by Country for Semaglutide
Location Trials
United States 635
India 91
China 51
Germany 50
Canada 47
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Trials by US State

Trials by US State for Semaglutide
Location Trials
Texas 32
California 32
Florida 29
Ohio 25
New York 25
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Clinical Trial Progress for Semaglutide

Clinical Trial Phase

Clinical Trial Phase for Semaglutide
Clinical Trial Phase Trials
Phase 4 8
Phase 3 44
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Semaglutide
Clinical Trial Phase Trials
Not yet recruiting 52
Completed 40
Recruiting 32
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Clinical Trial Sponsors for Semaglutide

Sponsor Name

Sponsor Name for Semaglutide
Sponsor Trials
Novo Nordisk A/S 111
Eli Lilly and Company 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
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Sponsor Type

Sponsor Type for Semaglutide
Sponsor Trials
Industry 117
Other 18
NIH 4
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