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Orforglipron for Obesity

Phase 1

Recruiting

Research Sponsored by Eli Lilly and Company

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

No Placebo-Only Group

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:

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 9 (cohort 1), week 15 (cohort 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met