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

NCT06440980
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Phase
Phase 1
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Recruitment status
Completed
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Participants
533
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Lead sponsor
Eli Lilly and Company
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Start date
2024-06-24
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Number of sites
7
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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 respectively, including the screening period.
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Short title
A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
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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.
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Control arm
Open label
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-06-02
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First posted
2024-06-04
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Registry last updated
2026-07-17
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Primary completion date
2025-06-02
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Start date
2024-06-24
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Actual participants
533
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Participants
533
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
7
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06440980
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ClinicalTrials.gov ID
NCT06440980
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part B: Pharmacokinetics (PK): Steady-state Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau]) of LY3502970 on Day 7

    Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)

    PK: Area under the concentration versus time curve from time 0 to the end of the once daily dosing interval at steady state AUC\[0-tau\] on Day 7.

  2. Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of LY3502970 on Day 7

    Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose on Day 7 for each dosing treatment period (1 period=7 days)

    PK: Maximum concentration of LY3502970 during a once daily dosing interval at steady state on Day 7.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • 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.

  • Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
  • Have a history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or other significant active, uncontrolled medical conditions.
  • 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.
Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical Trials, LLCAnaheim, United States
  • Collaborative Neuroscience Research, LLCLos Alamitos, United States
  • Fortrea Clinical Research UnitDaytona Beach, United States
  • Altasciences Company Inc.Overland Park, United States
  • QPSSpringfield, United States
  • Fortrea Clinical Research UnitDallas, United States
  • Fortrea Clinical Research UnitMadison, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J2A-MC-GZPI
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)