DelfaGLP-1 Atlas

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CompletedPhase 1Results posted

A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

A Drug-Drug Interaction Study to Assess the Effect of Orforglipron on the Pharmacokinetics of Digoxin, Simvastatin, Rosuvastatin, Acetaminophen, and Midazolam in Healthy Overweight and Obese Participants

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

50

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI ≥27•eGFR ≥60•Healthy volunteers

Primary endpoints

•AUC•PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following•PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid After Sodium

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06186622
Org study ID18631
Secondary IDJ2A-MC-GZPGEli Lilly and Company

Timeline

Milestones

Study first posted2024-01-02actual
Study start2024-01-02actual
Primary completion2024-07-10actual
Study completion2024-07-10actual
Last update posted2026-05-22actual
Results first posted2026-05-22actual

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Participants who are overtly healthy as determined by medical history and physical examination.
•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 any type of diabetes with 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 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.

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

32 endpoints
Primary/registry result

Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of Simvastatin and Its Metabolite Simvastatin Acid Following Simultaneous Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours (h) post-dose; Day 98 (Cohort 1) and Day 93 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanogram* hours per milliliter (ng*h/ml)95% CI
20 mg Simvastatin AloneSimvastatin22.1—
Metabolite- Simvastatin Acid13.6—
Simultaneous 36 mg Orforglipron Capsule + 20 mg SimvastatinSimvastatin18.8—
Metabolite- Simvastatin Acid23.3—
Primary/registry result

PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following Staggered Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 104 (Cohort 1) and Day 99 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/ml95% CI
20 mg Simvastatin AloneSimvastatin22.1—
Metabolite- Simvastatin Acid13.6—
Staggered 36 mg Orforglipron Capsule + 20 mg SimvastatinSimvastatin20.1—
Metabolite- Simvastatin Acid30.2—
Primary/registry result

PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid After Sodium Bicarbonate Coadministration (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 7 (Cohort 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/ml95% CI
20 mg Simvastatin AloneSimvastatin22.1—
Metabolite- Simvastatin Acid13.6—
20 mg Simultaneous Simvastatin + 600 mg Sodium BicarbonateSimvastatin20.3—
Metabolite- Simvastatin Acid14.0—
Primary/registry result

PK: AUC [0-∞] of Digoxin (Cohort 1 and 2)

Time frame:Day 2 (For Cohort 1 and 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose ; Day 99 (Cohort 1) and Day 94 (Cohort 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/ml95% CI
0.25 mg Digoxin Alone18.8—
Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin22.4—
Primary/registry result

PK: AUC [0-∞] of Rosuvastatin (Cohort 1 Only)

Time frame:Day 8 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose; Day 105 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/ml95% CI
20 mg Rosuvastatin Alone116—
Simultaneous 36 mg Orforglipron Capsule + 20 mg Rosuvastatin192—
Primary/registry result

PK: AUC [0-∞] of Acetaminophen (Cohort 1 Only)

Time frame:Day 10 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 14 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 107 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/ml95% CI
1000 mg Acetaminophen Alone59900—
Staggered 1 mg Orforglipron Capsule + 1000 mg Acetaminophen52900—
Staggered 36 mg Orforglipron Capsule + 1000 mg Acetaminophen73000—
Primary/registry result

PK: AUC [0-∞] of Midazolam and Its Metabolite 1'-Hydroxymidazolam (Cohort 1 Only)

Time frame:Day 12 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose; Day 109 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/ml95% CI
0.2 mg Midazolam AloneMidazolam3.82—
Metabolite- 1'-Hydroxymidazolam1.00—
Simultaneous 36 mg Orforglipron Capsule + 0.2 mg MidazolamMidazolam4.60—
Metabolite- 1'-Hydroxymidazolam1.34—
Primary/registry result

PK: Maximum Observed Concentration (Cmax) of Simvastatin and Its Metabolite Simvastatin Acid Following Simultaneous Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 98 (Cohort 1) and Day 93 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), Nanogram per milliliter (ng/ml)95% CI
20 mg Simvastatin AloneSimvastatin4.68—
Metabolite-Simvastatin Acid1.25—
Simultaneous 36 mg Orforglipron Capsule + 20 mg SimvastatinSimvastatin4.07—
Metabolite-Simvastatin Acid2.72—
Primary/registry result

PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid Following Staggered Administration of Orforglipron Capsule Formulation (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 104 (Cohort 1) and Day 99 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/ml95% CI
20 mg Simvastatin AloneSimvastatin4.68—
Metabolite- Simvastatin Acid1.25—
Staggered 36 mg Orforglipron Capsule + 20 mg SimvastatinSimvastatin3.34—
Metabolite- Simvastatin Acid2.94—
Primary/registry result

PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid After Sodium Bicarbonate Coadministration (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 7 (Cohort 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/ml95% CI
20 mg Simvastatin AloneSimvastatin4.68—
Metabolite- Simvastatin Acid1.25—
20 mg Simultaneous Simvastatin + 600 mg Sodium BicarbonateSimvastatin4.62—
Metabolite- Simvastatin Acid1.23—
Primary/registry result

PK: Cmax of Digoxin (Cohorts 1 and 2)

Time frame:Day 2 (For Cohort 1 and 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose; Day 99 (Cohort 1) and Day 94 (Cohort 2): Pre-dose, 0.5, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, and 120h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/ml95% CI
0.25 mg Digoxin Alone1.02—
Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin1.20—
Primary/registry result

PK: Cmax of Rosuvastatin (Cohort 1 Only)

Time frame:Day 8 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose; Day 105 (Cohort 1 only): Pre-dose, 0.5, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/ml95% CI
20 mg Rosuvastatin Alone11.4—
Simultaneous 36 mg Orforglipron Capsule + 20 mg Rosuvastatin14.2—
Primary/registry result

PK: Cmax of Acetaminophen (Cohort 1 Only)

Time frame:Day 10 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 14 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose; Day 107 (Cohort 1 only): Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/ml95% CI
1000 mg Acetaminophen Alone10800—
Staggered 1 mg Orforglipron Capsule + 1000 mg Acetaminophen7760—
Staggered 36 mg Orforglipron Capsule + 1000 mg Acetaminophen10800—
Primary/registry result

PK: Cmax of Midazolam and Its Metabolite 1'-Hydroxymidazolam (Cohort 1 Only)

Time frame:Day 12 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose; Day 109 (Cohort 1 only): Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 6, 9, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/ml95% CI
0.2 mg Midazolam AloneMidazolam1.23—
Metabolite- 1'-Hydroxymidazolam0.331—
Simultaneous 36 mg Orforglipron Capsule + 0.2 mg MidazolamMidazolam1.33—
Metabolite- 1'-Hydroxymidazolam0.357—
Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Simvastatin and simvastatin acid following simultaneous administration of Orforglipron capsule formulation

Time frame:Predose up to 24 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: AUC [0-∞] of Simvastatin and simvastatin acid following staggered administration of Orforglipron capsule formulation

Time frame:Predose up to 24 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: AUC [0-∞] of Simvastatin and simvastatin acid after sodium bicarbonate coadministration

Time frame:Predose up to 24 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: AUC [0-∞] of Digoxin

Time frame:Predose up to 120 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: AUC [0-∞] of Rosuvastatin

Time frame:Predose up to 72 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: AUC [0-∞] of Acetaminophen

Time frame:Predose up to 24 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: AUC [0-∞] of Midazolam and 1'-hydroxymidazolam

Time frame:Predose up to 24 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Concentration (Cmax) of Simvastatin and simvastatin acid following simultaneous administration of Orforglipron capsule formulation

Time frame:Predose up to 24 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Cmax of Simvastatin and simvastatin acid following staggered administration of Orforglipron capsule formulation

Time frame:Predose up to 24 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Cmax of Simvastatin and simvastatin acid after sodium bicarbonate coadministration

Time frame:Predose up to 24 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Cmax of Digoxin

Time frame:Predose up to 120 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Cmax of Rosuvastatin

Time frame:Predose up to 72 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Cmax of Acetaminophen

Time frame:Predose up to 24 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Cmax of Midazolam and 1'-hydroxymidazolam

Time frame:Predose up to 24 hours postdose

Cmax

concentration, descriptive

Secondary/registry result

PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following Administration of Orforglipron Tablet Formulation (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 111 (Cohort 1) and Day 101 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*h/ml95% CI
20 mg Simvastatin AloneSimvastatin22.1—
Metabolite- Simvastatin Acid13.6—
Simultaneous 20 mg Orforglipron Tablet + 20 mg SimvastatinSimvastatin21.0—
Metabolite- Simvastatin Acid29.3—
Secondary/registry result

PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid Following Administration of Orforglipron Tablet Formulation (Cohort 1 and 2)

Time frame:Day 1 (For Cohorts 1 and 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 h post-dose; Day 111 (Cohort 1) and Day 101 (Cohort 2): Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24h post-dose

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/ml95% CI
20 mg Simvastatin AloneSimvastatin4.68—
Metabolite- Simvastatin Acid1.25—
Simultaneous 20 mg Orforglipron Tablet + 20 mg SimvastatinSimvastatin3.78—
Metabolite- Simvastatin Acid3.00—
Secondary/protocol endpoint

PK: AUC [0-∞] of Simvastatin and simvastatin acid after administrating Orforglipron tablet formulation

Time frame:Predose up to 24 hours postdose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Cmax of Simvastatin and simvastatin acid after administrating Orforglipron tablet formulation

Time frame:Predose up to 24 hours postdose

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.