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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT06186622 (opens ClinicalTrials.gov in a new tab)Other id18631Other idJ2A-MC-GZPG
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
50 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
2 Jan 2024
Primary completion
10 Jul 2024
Completion
10 Jul 2024
First posted
2 Jan 2024
Last update posted
22 May 2026
Conditions
Healthy · Obese · Overweight

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025
  1. Ph 1

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

    NCT06186622

    2 Jan 2024 to 10 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to determine effect of orforglipron capsule formulation on the amount of digoxin, rosuvastatin, acetaminophen, midazolam, and simvastatin (each given alone and together with orforglipron) that enters the bloodstream and how long it takes the body to eliminate them when administered orally in healthy overweight and obese participants. In addition, the effect of the orforglipron tablet on the amount of simvastatin that enters the bloodstream and how long it takes the body to eliminate it will be evaluated. 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.

Interventions

  • OrforglipronDrug
  • SimvastatinDrug
  • DigoxinDrug
  • RosuvastatinDrug
  • AcetaminophenDrug
  • MidazolamDrug
  • Sodium BicarbonateDrug

Arms2

  • Experimental

    Cohort 1: Oral Drug Dosing With or Without Orforglipron Co-Administration

    Participants received single oral doses as follows:Day 1: 20 milligram(mg) simvastatin; Day 2: 0.25 mg digoxin; Day 7:20 mg simvastatin + 600 mg sodium bicarbonate; Day 8: 20 mg rosuvastatin; Day 10: 1000 mg acetaminophen; Day 12: 0.2 mg midazolam;Day 14: 1 mg Orforglipron, followed by 1000 mg acetaminophen administered 2 hours (±10 minutes) later (staggered); Day 15: 1 mg Orforglipron; Days 16-97: Orforglipron administered once daily with dose escalation every 14 days:1 mg (Days 16-27), 3 mg (Days 28-41),6 mg (Days 42-55),12 mg (Days 56-69),24 mg (Days 70-83),36 mg (Days 84-97). Days 98-110: 36 mg Orforglipron administered once daily with co administration as follows:Day 98: 20 mg simvastatin (simultaneous); Day 99: 0.25 mg digoxin (simultaneous); Day 104: 20 mg simvastatin (staggered); Day 105:20 mg rosuvastatin (simultaneous); Day 107: 1000 mg acetaminophen (staggered); Day 109:0.2 mg midazolam (simultaneous); Day 111: 20 mg Orforglipron tablet + 20 mg simvastatin (simultaneous).

  • Experimental

    Cohort 2: Oral Drug Dosing With or Without Orforglipron Co-Administration

    Participants received single oral doses as follows: Day 1: 20 mg Simvastatin; Day 2: 0.25 mg Digoxin; Day 7: 20 mg Simvastatin + 600 mg Sodium Bicarbonate; Day 9: 1 mg Orforglipron capsule; Days 10-90: Participants received orforglipron capsule orally QD for 12 weeks, beginning at 1 mg QD. The dose was escalated every 14 days as follows: 1 mg (Days 10-22), 3 mg (Days 23-36), 6 mg (Days 37-50), 12 mg (Days 51-64), 24 mg (Days 65-78), and 36 mg (Days 79-90). Participants continued 36 mg Orforglipron QD until Day 100, with co-administration of the following drugs; Day 93: 20 mg Simvastatin (simultaneous); Day 94: 0.25 mg Digoxin (simultaneous); Day 99: 20 mg Simvastatin administered 2 hours ±10 minutes after Orforglipron administration (staggered dosing); Day 101: 20 mg Orforglipron tablet + 20 mg Simvastatin (simultaneous)

Primary outcomes14

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    AUC \[0-∞\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.

  2. 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

    Registry description

    AUC \[0-∞\] of simvastatin and its active acid metabolite (simvastatin acid) following staggered administration with or without Orforglipron capsule were reported in this outcome measure. Simvastatin was administered \~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).

  3. 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

    Registry description

    AUC \[0-∞\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without sodium bicarbonate administration were reported in this outcome measure.

  4. 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

  5. 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

  6. 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

    Registry description

    AUC \[0-∞\] of acetaminophen following staggered administration with or without either 1 mg or 36 mg Orforglipron capsule were reported in this outcome measure. Acetaminophen was administered \~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).

  7. 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

    Registry description

    AUC \[0-∞\] of midazolam and its metabolite (1'-Hydroxymidazolam) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.

  8. 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

    Registry description

    Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron capsule were reported in this outcome measure.

  9. 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

    Registry description

    Cmax of simvastatin and its active acid metabolite (simvastatin acid) following staggered administration with or without Orforglipron capsule were reported in this outcome measure. Simvastatin was administered \~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).

  10. 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

    Registry description

    Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without sodium bicarbonate administration were reported in this outcome measure.

  11. 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

  12. 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

  13. 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

    Registry description

    Cmax of acetaminophen following staggered administration with or without either 1 mg or 36 mg Orforglipron capsule were reported in this outcome measure. Acetaminophen was administered \~2h (±10 min) after Orforglipron capsule administration (Staggered dosing).

  14. 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

    Registry description

    Cmax of Midazolam and its metabolite (1'-Hydroxymidazolam) following simultaneous administration with or without Orforglipron capsule is reported in this outcome measure.

Secondary outcomes(2)

  1. 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

    Registry description

    AUC \[0-∞\] of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron tablet were reported in this outcome measure.

  2. 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

    Registry description

    Cmax of simvastatin and its active acid metabolite (simvastatin acid) following simultaneous administration with or without Orforglipron tablet were reported in this outcome measure.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· 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

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)

GroupValue (Nanogram* hours per milliliter (ng*h/ml))Spread
20 mg Simvastatin Alone22.179.2
Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin18.884.3
Primary outcomeGeometric mean· 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

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

GroupValue (ng*h/ml)Spread
20 mg Simvastatin Alone22.179.2
Staggered 36 mg Orforglipron Capsule + 20 mg Simvastatin20.176.5
Primary outcomeGeometric mean· 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

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

GroupValue (ng*h/ml)Spread
20 mg Simvastatin Alone22.179.2
20 mg Simultaneous Simvastatin + 600 mg Sodium Bicarbonate20.382.8
Primary outcomeGeometric mean· 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

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

GroupValue (ng*h/ml)Spread
0.25 mg Digoxin Alone18.821.5
Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin22.426.5
Primary outcomeGeometric mean· 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

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

GroupValue (ng*h/ml)Spread
20 mg Rosuvastatin Alone11652.1
Simultaneous 36 mg Orforglipron Capsule + 20 mg Rosuvastatin19260.1
Primary outcomeGeometric mean· 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

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

GroupValue (ng*h/ml)Spread
1000 mg Acetaminophen Alone5990037.2
Staggered 1 mg Orforglipron Capsule + 1000 mg Acetaminophen5290039.0
Staggered 36 mg Orforglipron Capsule + 1000 mg Acetaminophen7300064.3
Primary outcomeGeometric mean· 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

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

GroupValue (ng*h/ml)Spread
0.2 mg Midazolam Alone3.8241.2
Simultaneous 36 mg Orforglipron Capsule + 0.2 mg Midazolam4.6047.3
Primary outcomeGeometric mean· 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

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

GroupValue (Nanogram per milliliter (ng/ml))Spread
20 mg Simvastatin Alone4.6880.3
Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin4.0789.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Cohort 1: 20 mg Simvastatin Alone (Day 1)Participants received single dose of 20 mg simvastatin alone orally on Day 1.0 / 300 / 302 / 30
Cohort 1: 0.25 mg Digoxin Alone (Day 2)Participants received 0.25 mg digoxin alone on Day 2.0 / 300 / 300 / 30
Cohort 1: 20 mg Simvastatin + 600 mg Sodium Bicarbonate (Day 7)Participants received simultaneous dosing of 20 mg simvastatin and 600 mg sodium bicarbonate orally on Day 7.0 / 280 / 280 / 28
Cohort 1: 20 mg Rosuvastatin Alone (Day 8)Participants received single dose of 20 mg rosuvastatin alone orally on Day 8.0 / 280 / 280 / 28
Cohort 1: 1000 mg Acetaminophen Alone (Day 10)Participants received single dose of 1000 mg acetaminophen alone orally on Day 10.0 / 270 / 271 / 27
Cohort 1: 0.2 mg Midazolam Alone (Day 12)Participants received single dose of 0.2 mg midazolam alone orally on Day 12.0 / 270 / 270 / 27
Cohort 1: Staggered 1 mg Orforglipron Capsule + 1000 mg Acetaminophen (Day 14)Participants received staggered dosing of 1 mg single dose of Orforglipron followed by 1000 mg acetaminophen orally on Day 14.0 / 270 / 271 / 27
Cohort 1: 1 mg Orforglipron Capsule QD (Day 15 to Day 27)Participants received 1 mg Orforglipron capsule once daily from Day 15 through Day 27.0 / 270 / 274 / 27
Cohort 1: 3 mg Orforglipron Capsule QD (Day 28 to Day 41)Participants received 3 mg Orforglipron capsule once daily from Day 28 through Day 41.0 / 260 / 262 / 26
Cohort 1: 6 mg Orforglipron Capsule QD (Day 42 to Day 55)Participants received 6 mg Orforglipron capsule once daily from Day 42 through Day 55.0 / 260 / 265 / 26
Cohort 1: 12 mg Orforglipron Capsule QD (Day 56 to Day 69)Participants received 12 mg Orforglipron capsule once daily from Day 56 through Day 69.0 / 260 / 262 / 26
Cohort 1: 24 mg Orforglipron Capsule QD (Day 70 to Day 83)Participants received 24 mg Orforglipron capsule once daily from Day 70 through Day 83.0 / 260 / 262 / 26
Cohort 1: 36 mg Orforglipron Capsule QD (Day 84 to Day 97)Participants received 36 mg Orforglipron capsule once daily from Day 84 through Day 97.0 / 260 / 2611 / 26
Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin (Day 98)Participants received simultaneous dosing of 20 mg simvastatin and 36 mg Orforglipron orally on Day 98.0 / 220 / 220 / 22
Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin (Day 99)Participants received simultaneous dosing of 0.25 mg digoxin and 36 mg Orforglipron orally on Day 99.0 / 220 / 222 / 22
Cohort 1: 36 mg Orforglipron Capsule QD (Day 100 to Day 103)Participants received 36 mg Orforglipron capsule once daily from Day 100 through Day 103.0 / 220 / 222 / 22
Cohort 1: Staggered 36 mg Orforglipron Capsule + 20 mg Simvastatin (Day 104)Participants received staggered dosing of 36 mg Orforglipron followed by 20 mg Simvastatin orally on Day 104.0 / 220 / 220 / 22
Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 20 mg Rosuvastatin (Day 105)Participants received simultaneous dosing of 20 mg rosuvastatin and 36 mg Orforglipron orally on Day 105.0 / 220 / 222 / 22
Cohort 1: 36 mg Orforglipron Capsule (Day 106)Participants received 36 mg Orforglipron orally on Day 106.0 / 220 / 222 / 22
Cohort 1: Staggered 36 mg Orforglipron Capsule + 1000 mg Acetaminophen (Day 107)Participants received staggered dosing of 36 mg Orforglipron capsule followed by 1000 mg acetaminophen orally on Day 107.0 / 220 / 221 / 22
Cohort 1: 36 mg Orforglipron Capsule (Day 108)Participants received 36 mg Orforglipron orally on Day 108.0 / 220 / 221 / 22
Cohort 1: Simultaneous 36 mg Orforglipron Capsule + 0.2 mg Midazolam (Day 109)Participants received simultaneous dosing of 0.2 mg midazolam and 36 mg Orforglipron orally on Day 109.0 / 210 / 211 / 21
Cohort 1: 36 mg Orforglipron Capsule (Day 110)Participants received 36 mg Orforglipron orally on Day 110.0 / 220 / 220 / 22
Cohort 1: Simultaneous 20 mg Orforglipron Tablet + 20 mg Simvastatin (Day 111)Participants received simultaneous dosing of 20 mg simvastatin and 20 mg Orforglipron orally on Day 111.0 / 220 / 222 / 22
Cohort 2: 20 mg Simvastatin Alone (Day 1)Participants received single dose of 20 mg simvastatin alone orally on Day 1.0 / 200 / 201 / 20
Cohort 2: 0.25 mg Digoxin Alone (Day 2)Participants received 0.25 mg digoxin alone on Day 2.0 / 200 / 200 / 20
Cohort 2: Simultaneous 20 mg Simvastatin + 600 mg Sodium Bicarbonate (Day 7)Participants received simultaneous dosing of 20 mg simvastatin and 600 mg sodium bicarbonate orally on Day 7.0 / 200 / 200 / 20
Cohort 2: 1 mg Orforglipron Capsule QD (Day 9 to Day 22)Participants received 1 mg Orforglipron capsule once daily from Day 9 through Day 22.0 / 200 / 209 / 20
Cohort 2: 3 mg Orforglipron Capsule QD (Day 23 to Day 36)Participants received 3 mg Orforglipron capsule once daily from Day 23 through Day 36.0 / 200 / 207 / 20
Cohort 2: 6 mg Orforglipron Capsule QD (Day 37 to Day 50)Participants received 6 mg Orforglipron capsule once daily from Day 37 through Day 50.0 / 190 / 196 / 19
Cohort 2: 12 mg Orforglipron Capsule QD (Day 51 to Day 64)Participants received 12 mg Orforglipron capsule once daily from Day 51 through Day 64.0 / 191 / 196 / 19
Cohort 2: 24 mg Orforglipron Capsule QD (Day 65 to Day 78)Participants received 24 mg Orforglipron capsule once daily from Day 65 through Day 78.0 / 180 / 184 / 18
Cohort 2: 36 mg Orforglipron Capsule QD (Day 79 to Day 92)Participants received 36 mg Orforglipron capsule once daily from Day79 through Day 92.0 / 180 / 1810 / 18
Cohort 2: Simultaneous 36 mg Orforglipron Capsule + 20 mg Simvastatin (Day 93)Participants received simultaneous dosing of 20 mg simvastatin and 36 mg Orforglipron orally on Day 93.0 / 160 / 161 / 16
Cohort 2: Simultaneous 36 mg Orforglipron Capsule + 0.25 mg Digoxin (Day 94)Participants received simultaneous dosing of 0.25 mg digoxin and 36 mg Orforglipron orally on Day 94.0 / 160 / 161 / 16
Cohort 2: 36 mg Orforglipron Capsule QD (Day 95 to Day 98)Participants received 36 mg Orforglipron capsule once daily from Day 95 through Day 98.0 / 160 / 162 / 16
Cohort 2: Staggered 36 mg Orforglipron Capsule + 20 mg Simvastatin (Day 99)Participants received staggered dosing of 36 mg Orforglipron followed by 20 mg Simvastatin orally on Day 99.0 / 160 / 161 / 16
Cohort 2: 36 mg Orforglipron Capsule (Day 100)Participants received 36 mg Orforglipron capsule orally on Day 100.0 / 160 / 160 / 16
Cohort 2: Simultaneous 20 mg Orforglipron Tablet + 20 mg Simvastatin (Day 101)Participants received simultaneous dosing of 20 mg simvastatin and 20 mg Orforglipron orally on Day 101.0 / 160 / 163 / 16

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.