A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight

Healthy Clinical Trial

Official title:

A Multiple-Dose Study to Investigate the Bioequivalence of Orforglipron (LY3502970) Capsules and Orforglipron Tablets in Participants With Obesity or Overweight Who Are Otherwise Healthy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06440980
• Other study ID #: 18617
• Secondary ID: J2A-MC-GZPI
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 24, 2024
• Est. completion date: May 21, 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]Lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each, including the screening period.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 508
• Est. completion date: May 21, 2025
• Est. primary completion date: May 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical history and physical examination.
• Have a stable body weight for one month prior to screening (less than or equal to 5 percent body weight gain or loss) and Body Mass Index (BMI) in range of 27 to 40 kilogram per meter square (kg/m²).
• Participants must be reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
• Have venous access sufficient to allow for blood sampling.

Exclusion Criteria:

• Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
• Have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years.
• Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome.
• Have known clinically significant gastric emptying abnormality.
• Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
• Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer.
• Have an abnormal 12-lead electrocardiogram (ECG) at screening.
• Have history of pancreatitis.
• Judged by the study investigator to be at serious suicidal risk and have answered "Yes" to either question 4 or 5 on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
• Have difficulty swallowing capsules or tablets.

Related Conditions & MeSH terms

• Healthy
• Obese
• Obesity
• Overweight

Intervention

Drug:
• Orforglipron
Administered orally

Locations

Country	Name	City	State
United States	Fortrea CRU, Inc.	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to t hour time point AUC(0-t) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths	t is 24 hours for once daily (QD) dosing	Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Primary	Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths		Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Secondary	Part B: PK: Steady-state AUC(0-t) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths	t is 24 hours for QD dosing	Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Secondary	Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths		Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)