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Orforglipron (Part 2) 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

Have an estimated glomerular filtration rate equal to or greater than 60 milliliters per square meter (mL/m2).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose up to 120 hours postdose

Awards & highlights

Study Summary

This trial aims to investigate the effects of a medication called orforglipron on the levels and elimination of certain drugs in the body. The study will be conducted on healthy overweight and obese participants. It

Who is the study for?

This trial is for healthy overweight and obese individuals. Participants should not have any other significant health issues that could interfere with the study.Check my eligibility

What is being tested?

The study is testing how orforglipron affects the absorption and elimination of several drugs (digoxin, rosuvastatin, acetaminophen, midazolam, simvastatin) in overweight/obese people. It also examines the impact of sodium bicarbonate on drug levels when taken with orforglipron.See study design

What are the potential side effects?

Possible side effects include reactions to orforglipron or other studied drugs such as digestive discomfort, headaches, dizziness, potential liver enzyme changes, and allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney function is normal or only mildly reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 120 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 120 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 120 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PK: AUC [0-∞] of Acetaminophen

PK: AUC [0-∞] of Digoxin

PK: AUC [0-∞] of Midazolam and 1'-hydroxymidazolam

+11 more

Secondary outcome measures

PK: AUC [0-∞] of Simvastatin and simvastatin acid after administrating Orforglipron tablet formulation

PK: Cmax of Simvastatin and simvastatin acid after administrating Orforglipron tablet formulation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Orforglipron (Part 2)Experimental Treatment4 Interventions

Participants will receive Orforglipron capsule and tablet formulation with Simvastatin, Digoxin and Sodium Bicarbonate administered orally.

Group II: Orforglipron (Part 1)Experimental Treatment7 Interventions

Participants will receive Orforglipron capsule and tablet formulation with Simvastatin, Digoxin, Rosuvastatin, Acetaminophen, Midazolam and Sodium Bicarbonate administered orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midazolam

2018

Completed Phase 4

~1910

Digoxin

2017

Completed Phase 4

~670

Sodium Bicarbonate

2015

Completed Phase 4

~1610

Simvastatin

2012

Completed Phase 4

~1270

Rosuvastatin

2019

Completed Phase 4

~3150

Acetaminophen

2017

Completed Phase 4

~2030

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,620 Previous Clinical Trials

3,216,549 Total Patients Enrolled

56 Trials studying Obesity

51,219 Patients Enrolled for Obesity

Study DirectorEli Lilly and Company

1,348 Previous Clinical Trials

415,695 Total Patients Enrolled

39 Trials studying Obesity

30,938 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"As per the information on clinicaltrials.gov, this particular clinical trial is not presently accepting participants. The trial was initially posted on January 2nd, 2024 and was most recently updated on December 16th, 2023. However, it's important to note that there are currently 1093 other active trials actively seeking individuals for participation at this time."

Answered by AI

Does the enrollment for this medical study include individuals who are older than 30 years?

"The inclusion criteria for this clinical trial mandate that eligible participants fall within the age range of 18 to 70. It is worth noting that there are currently 105 trials available specifically targeting individuals under the age of 18, while an additional 591 trials cater to those over the age of 65."

Answered by AI

Has the Food and Drug Administration granted approval for the use of Orforglipron (Part 1) in medical practice?

"Given the limited data supporting safety and efficacy, our team at Power rates Orforglipron (Part 1) with a safety score of 1 on a scale from 1 to 3. This rating aligns with it being in Phase 1 of the trial process."

Answered by AI

Who else is applying?

What site did they apply to?

Fortrea Clinical Research Unit Inc.

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

Why did patients apply to this trial?

To loose weight lower my blood pressure lower my blood sugar levels lower my cholesterol.

PatientReceived no prior treatments

I really would like to help with research studies. I think I can help with weight and endocrine research. I have tried everything to lose weight and nothing has worked so far. I would really like to help patients like myself find something that could help and understand why it happens.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

2024. "A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06186622.

All > Overweight