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LY2189265 and Atorvastatin Interaction Study
Plain-language guide to NCT01250834: phase 1 interventional trial of Dulaglutide, 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01250834
- Phase
- phase 1
- Status
- completed
- Start
- 2010-12
- Completion (planned or actual)
- 2011-03
- Participants
- 27 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Volunteers
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Dulaglutide.
This study will assess if giving LY2189265 at the same time as atorvastatin affects how the body absorbs atorvastatin.
It had 1 arm (groups): LY2189265 + Atorvastatin (experimental).
The registry classes the interventions as biological and drug.
Who Took Part
Enrollment: 27 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Have a body mass index (BMI) between 18.5 and 30.0 kilograms per square meter (kg/m\^2), inclusive. Have venous access sufficient to allow frequent blood sampling. Are reliable and willing to make themselves available for the duration of the study and are willing to follow the study restrictions.
The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: have known allergies or intolerance to atorvastatin; have known allergies to glucagon-like peptide-1 (glp-1)-related compounds including ly2189265; have a history or presence of thyroid disease.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Dulaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2010-12 with completion listed for 2011-03.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Dulaglutide in 27 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Dulaglutide compound page, all human trials.
Our Notes on the Compound
Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.