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A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

2019-07-12 08:36:57 | BioPortfolio

Summary

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the stomach with the use of a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject themselves with the medicine. As part of this training participants will self inject placebo (dummy medication) 3 times. Participants will take an injection once a week and will get 21 injections in total of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.

Study Design

Conditions

Overweight

Intervention

Semaglutide (administered by DV3396 pen), Semaglutide (administered by PDS290 pen)

Location

Novo Nordisk Investigational Site
Mainz
Germany
55116

Status

Not yet recruiting

Source

Novo Nordisk A/S

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-12T08:36:57-0400

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Medical and Biotech [MESH] Definitions

A status with BODY WEIGHT that is above certain standard of acceptable or desirable weight. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal "over fat".

The use of multiple drugs administered to the same patient, most commonly seen in elderly patients. It includes also the administration of excessive medication. Since in the United States most drugs are dispensed as single-agent formulations, polypharmacy, though using many drugs administered to the same patient, must be differentiated from DRUG COMBINATIONS, single preparations containing two or more drugs as a fixed dose, and from DRUG THERAPY, COMBINATION, two or more drugs administered separately for a combined effect. (From Segen, Dictionary of Modern Medicine, 1992)

An antineoplastic antimetabolite that is metabolized to fluorouracil when administered by rapid injection; when administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. It has been used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract.

A group of islands of SAMOA, in the southwest central Pacific. Its capital is Pago Pago. The islands were ruled by native chiefs until about 1869. An object of American interest beginning in 1839, Pago Pago and trading and extraterritorial rights were granted to the United States in 1878. The United States, Germany, and England administered the islands jointly 1889-99, but in 1899 they were granted to the United States by treaty. The Department of the Interior has administered American Samoa since 1951. (From Webster's New Geographical Dictionary, 1988, p44)

Treatment in which a repeat course of RADIOTHERAPY is administered.

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