Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/27/2019 |
| Start Date: | March 1, 2019 |
| End Date: | April 10, 2020 |
| Contact: | Novo Nordisk |
| Email: | clinicaltrials@novonordisk.com |
| Phone: | (+1) 866-867-7178 |
Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.
This study will look at the change in body weight in people taking NNC0174-0833, liraglutide
and "dummy" medicine, from the start to the end of the study. As well as taking the medicine,
participants will have talks with study staff about healthy food choices, how to be more
physically active and what participants can do to lose weight. Participants will either take
NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided
by chance. Participants will need to take one injection once a week or once a day, depending
on the treatment. The study medicine is injected with a thin needle in a skin fold in the
stomach, thigh or upper arm. The study will last for about 8 months. Participants will have
12 clinic visits with the study doctor.
and "dummy" medicine, from the start to the end of the study. As well as taking the medicine,
participants will have talks with study staff about healthy food choices, how to be more
physically active and what participants can do to lose weight. Participants will either take
NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided
by chance. Participants will need to take one injection once a week or once a day, depending
on the treatment. The study medicine is injected with a thin needle in a skin fold in the
stomach, thigh or upper arm. The study will last for about 8 months. Participants will have
12 clinic visits with the study doctor.
Inclusion Criteria:
- 18 years or older at the time of signing the informed consent.
- Female subject of non-childbearing potential or Male subject who is surgically
sterilised (vasectomy) or who is willing to use adequate contraceptive methods (as
required by local regulation or practice) throughout the trial (until 'end of trial').
- BMI equal to 30.0 kg/m^2 or greater or BMI equal to 27.0 kg/m^2 or greater with the
presence of at least one of the following weight-related comorbidities (treated or
untreated): hypertension or dyslipidaemia (to be assessed at the investigator's
discretion).
Exclusion Criteria:
- HbA1c equal to 48 mmol/mol (6.5 percentage) or greater as measured by the central
laboratory at screening.
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days prior
to screening irrespective of medical records.
We found this trial at
22
sites
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