STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 4, 2018
End Date:April 20, 2020

Use our guide to learn which trials are right for you!

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity

This study will look at the change in participants' body weight from the start to the end of
the study. The weight loss in participants taking semaglutide (a new medicine) will be
compared to the weight loss of participants taking "dummy" medicine. In addition to taking
the medicine, participants will have talks with study staff about healthy food choices, how
to be more physically active and what you can do to lose weight. Participants will either get
semaglutide or "dummy" medicine - which treatment participants get, is decided by chance.
Participants will need to take 1 injection once a week. The study medicine is injected with a
thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A
main phase and an extension phase.The main phase will last for about 1.5 years. Participants
will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase:
Approximately 300 participants will continue in the extension phase in the following
countries only: Canada, Germany, the UK and selected sites in the US and Japan. These
participants will be in the study for about 2.5 years.They will not receive treatment, but
will attend another 5 follow-up visits with the study doctor.


Inclusion Criteria:

Main phase:

- Male or female, age greater than or equal to 18 years at the time of signing informed
consent

- Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to
27.0 kg/sqm with the presence of at least one of the following weight-related
comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep
apnoea or cardiovascular disease

- History of at least one self-reported unsuccessful dietary effort to lose body weight

Extension phase:

- Informed consent for the extension phase obtained before any trial related activities
for the extension phase

- On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg
semaglutide once-weekly or semaglutide placebo

Exclusion Criteria:

Main phase:

- Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured
by the central laboratory at screening

- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before
screening irrespective of medical records

Extension phase:

- Female who is pregnant or intends to become pregnant during the extension phase

- Any disorder, unwillingness or inability, not covered by any of the other exclusion
criteria, which in the investigator's opinion, might jeopardise the subject's
compliance with the extension of the trial
We found this trial at
36
sites
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Anniston, Alabama 36207
?
mi
from
Anniston, AL
Click here to add this to my saved trials
Aurora, Colorado 80010
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bountiful, Utah 84010
?
mi
from
Bountiful, UT
Click here to add this to my saved trials
Buckley, Michigan 49620
?
mi
from
Buckley, MI
Click here to add this to my saved trials
Butte, Montana 59701
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Caba,
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chiefland, Florida 32626
?
mi
from
Chiefland, FL
Click here to add this to my saved trials
Crystal River, Florida 34429
?
mi
from
Crystal River, FL
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Lomita, California 90717
?
mi
from
Lomita, CA
Click here to add this to my saved trials
Louisville, Kentucky 40213
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Omaha, Nebraska 68114
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Panama City, Florida 32401
?
mi
from
Panama City, FL
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Ponte Vedra, Florida 32081
?
mi
from
Ponte Vedra, FL
Click here to add this to my saved trials
Renton, Washington 98057
?
mi
from
Renton, WA
Click here to add this to my saved trials
Richmond, Virginia 23219
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, New York 14609
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Roswell, Georgia 30076
?
mi
from
Roswell, GA
Click here to add this to my saved trials
Round Rock, Texas 78681
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
Saint Peters, Missouri 63376
?
mi
from
Saint Peters, MO
Click here to add this to my saved trials
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
Simpsonville, South Carolina 29681
?
mi
from
Simpsonville, SC
Click here to add this to my saved trials
Spring Valley, California 91978
?
mi
from
Spring Valley, CA
Click here to add this to my saved trials
Topeka, Kansas 66606
?
mi
from
Topeka, KS
Click here to add this to my saved trials
Waterbury, Connecticut 06708
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
West Reading, Pennsylvania 19611
?
mi
from
West Reading, PA
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials