Clinical trial NCT06440980: A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Obese
Overweight
Obesity
Keywords: Pharmacokinetics
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
measure: 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
timeFrame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Secondary outcomes:
measure: 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
timeFrame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
measure: Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths
timeFrame: Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit
state: Florida
city: Overland Park
country: United States
facility: Altasciences Company Inc.
state: Kansas
city: Springfield
country: United States
facility: QPS
state: Missouri
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit
state: Texas
city: Madison
country: United States
facility: Fortrea Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: