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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Have difficulty swallowing capsules or tablets
Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to week 9 (cohort 1), week 15 (cohort 2)
Awards & highlights
Summary
"This trial aims to compare how the body absorbs and eliminates a new drug called orforglipron when taken as capsules versus tablets in overweight and obese individuals. The study will also assess the safety and side
Who is the study for?
This trial is for healthy adults who are overweight or obese. Participants will be given the study drug, Orforglipron, in two different forms: capsules and tablets. The trial aims to understand how the body absorbs and processes these forms.
What is being tested?
The focus of this study is on comparing the absorption into the bloodstream and elimination from the body of Orforglipron when administered as a tablet versus a capsule. It's divided into two parts, each lasting about 22-25 weeks including screening.
What are the potential side effects?
Potential side effects include any adverse reactions that participants might experience from taking Orforglipron in either form—capsules or tablets. Specific side effects aren't listed but will be monitored for safety and tolerability.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have trouble swallowing pills.
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I have had major depression or psychiatric issues in the past 2 years.
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My obesity is caused by an endocrine disorder like Cushing's or Prader-Willi syndrome.
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I have had weight loss surgery.
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I have had pancreatitis before.
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I or my close family have a history of specific thyroid conditions or cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 up to week 9 (cohort 1), week 15 (cohort 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to week 9 (cohort 1), week 15 (cohort 2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to τ hour time point AUC(0-τ) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths
Secondary outcome measures
Part B: PK: Steady-state AUC(0-τ) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B: BE (bioequivalence) study: Cohort 1 and 2: OrforglipronExperimental Treatment1 Intervention
Participants will receive different sequences of orforglipron doses administered as either tablet (different dose levels) or capsule (test dose levels 1 to 6).
Group II: Part A: Relative bioavailability study: Cohort 1 and 2: OrforglipronExperimental Treatment1 Intervention
Participants will receive different sequences of orforglipron doses administered as either tablet or capsule at different dose levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Orforglipron
2024
Completed Phase 1
~80
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,136 Total Patients Enrolled
60 Trials studying Obesity
52,079 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,582 Total Patients Enrolled
42 Trials studying Obesity
31,621 Patients Enrolled for Obesity
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