A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
NCT ID: NCT06186622
Last Updated: 2024-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2024-01-02
2024-07-10
Brief Summary
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The study will also assess the effect of sodium bicarbonate when administered alone with simvastatin versus orforglipron capsule containing sodium bicarbonate administered with simvastatin. The safety and tolerability of orforglipron and information about any side effects experienced will be collected.
Study will be conducted in two parts, with part 1 and 2 lasting up to approximately 23 and 24 weeks each, including the screening period.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Orforglipron (Part 1)
Participants will receive Orforglipron capsule and tablet formulation with Simvastatin, Digoxin, Rosuvastatin, Acetaminophen, Midazolam and Sodium Bicarbonate administered orally.
Orforglipron
Administered orally.
Simvastatin
Administered orally.
Digoxin
Administered orally.
Rosuvastatin
Administered orally.
Acetaminophen
Administered orally.
Midazolam
Administered orally.
Sodium Bicarbonate
Administered orally.
Orforglipron (Part 2)
Participants will receive Orforglipron capsule and tablet formulation with Simvastatin, Digoxin and Sodium Bicarbonate administered orally.
Orforglipron
Administered orally.
Simvastatin
Administered orally.
Digoxin
Administered orally.
Sodium Bicarbonate
Administered orally.
Interventions
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Orforglipron
Administered orally.
Simvastatin
Administered orally.
Digoxin
Administered orally.
Rosuvastatin
Administered orally.
Acetaminophen
Administered orally.
Midazolam
Administered orally.
Sodium Bicarbonate
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have body mass index (BMI) equal to or greater than 27 kilograms per meter squared (kg/m²), inclusive, at screening.
* Have an estimated glomerular filtration rate equal to or greater than 60 milliliters per minute (mL/min).
* Males and females who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
* Have venous access sufficient to allow for blood sampling.
Exclusion Criteria
* 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 significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug.
* Participants must not be currently participating in or completed a clinical trial within the last 90 days.
* Have a known allergy or hypersensitivity to midazolam, simvastatin, rosuvastatin, or digoxin.
18 Years
70 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Fortrea Clinical Research Unit Inc.
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States
Countries
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Other Identifiers
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J2A-MC-GZPG
Identifier Type: OTHER
Identifier Source: secondary_id
18631
Identifier Type: -
Identifier Source: org_study_id
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