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OpenTrials
Completed

NCT Number: NCT06440980

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Orforglipron

Drug

Administered orally

Other names: LY3502970

Primary outcomes

  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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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