Trial Outcomes & Findings for A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants (NCT NCT06370728)
NCT ID: NCT06370728
Last Updated: 2026-07-17
Results Overview
PK: AUC (0-∞) of Orforglipron
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)
Results posted on
2026-07-17
Participant Flow
Participant milestones
| Measure |
Orforglipron + Carbamazepine
Participants received study intervention through oral administration as follows:
* Day 1: 1 milligram (mg) orforglipron capsule alone
* Days 6 to 8: Twice daily (BID) doses of 100 mg carbamazepine tablets
* Days 9 to 11: BID doses of 200 mg carbamazepine tablets
* Days 12 to 14: BID doses of 300 mg carbamazepine tablets
* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets
* Days 16 to 18: BID doses of 300 mg carbamazepine tablets
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Safety Population Day 1
|
30
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Orforglipron + Carbamazepine
Participants received study intervention through oral administration as follows:
* Day 1: 1 milligram (mg) orforglipron capsule alone
* Days 6 to 8: Twice daily (BID) doses of 100 mg carbamazepine tablets
* Days 9 to 11: BID doses of 200 mg carbamazepine tablets
* Days 12 to 14: BID doses of 300 mg carbamazepine tablets
* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets
* Days 16 to 18: BID doses of 300 mg carbamazepine tablets
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
Baseline Characteristics
A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants
Baseline characteristics by cohort
| Measure |
Orforglipron + Carbamazepine
n=30 Participants
Participants received study intervention through oral administration as follows:
* Day 1: 1 mg orforglipron capsule alone
* Days 6 to 8: BID doses of 100 mg carbamazepine tablets
* Days 9 to 11: BID doses of 200 mg carbamazepine tablets
* Days 12 to 14: BID doses of 300 mg carbamazepine tablets
* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets
* Days 16 to 18: BID doses of 300 mg carbamazepine tablets
|
|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 12.3 • n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)Population: All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.
PK: AUC (0-∞) of Orforglipron
Outcome measures
| Measure |
Orforglipron + Carbamazepine
n=30 Participants
Participants received study intervention through oral administration as follows:
* Day 1: 1 mg orforglipron capsule alone
* Days 6 to 8: BID doses of 100 mg carbamazepine tablets
* Days 9 to 11: BID doses of 200 mg carbamazepine tablets
* Days 12 to 14: BID doses of 300 mg carbamazepine tablets
* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets
* Days 16 to 18: BID doses of 300 mg carbamazepine tablets
|
|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron
Day 1 (Orforglipron alone)
|
104 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 26.6
|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron
Day 15 (Orforglipron + Carbamazepine)
|
18.5 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 41.7
|
PRIMARY outcome
Timeframe: Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)Population: All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.
PK: AUC (0-tlast) of Orforglipron
Outcome measures
| Measure |
Orforglipron + Carbamazepine
n=30 Participants
Participants received study intervention through oral administration as follows:
* Day 1: 1 mg orforglipron capsule alone
* Days 6 to 8: BID doses of 100 mg carbamazepine tablets
* Days 9 to 11: BID doses of 200 mg carbamazepine tablets
* Days 12 to 14: BID doses of 300 mg carbamazepine tablets
* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets
* Days 16 to 18: BID doses of 300 mg carbamazepine tablets
|
|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
Day 1 (Orforglipron alone)
|
93.4 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 24.6
|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
Day 15 (Orforglipron + Carbamazepine)
|
15.8 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 51.8
|
PRIMARY outcome
Timeframe: Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)Population: All enrolled participants who received at least one dose of orforglipron and had evaluable PK data on the respective dosing days for this outcome analysis.
PK: Cmax of Orforglipron
Outcome measures
| Measure |
Orforglipron + Carbamazepine
n=30 Participants
Participants received study intervention through oral administration as follows:
* Day 1: 1 mg orforglipron capsule alone
* Days 6 to 8: BID doses of 100 mg carbamazepine tablets
* Days 9 to 11: BID doses of 200 mg carbamazepine tablets
* Days 12 to 14: BID doses of 300 mg carbamazepine tablets
* Day 15: 1 mg orforglipron capsule co-administered with BID doses of 300 mg carbamazepine tablets
* Days 16 to 18: BID doses of 300 mg carbamazepine tablets
|
|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Orforglipron
Day 1 (Orforglipron alone)
|
4.97 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31.0
|
|
PK: Maximum Observed Concentration (Cmax) of Orforglipron
Day 15 (Orforglipron + Carbamazepine)
|
2.22 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47.3
|
Adverse Events
Orforglipron Alone (Days 1-5)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Carbamazepine Alone (Days 6-18 Except Day 15, and Days 19-35)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Orforglipron + Carbamazepine Combination (Day 15)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Orforglipron Alone (Days 1-5)
n=30 participants at risk
Participants observed for adverse events during Orforglipron alone on Day 1 and post-dose observation period (Days 2-5) prior to Carbamazepine initiation were reported under this arm.
|
Carbamazepine Alone (Days 6-18 Except Day 15, and Days 19-35)
n=29 participants at risk
Participants observed for adverse events during Carbamazepine alone (Days 6-18 except Day 15) and follow-up period (Days 19-35) were reported under this arm.
|
Orforglipron + Carbamazepine Combination (Day 15)
n=28 participants at risk
Participants observed for adverse events during Orforglipron + Carbamazepine combination on Day 15 were reported under this arm.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
6.9%
2/29 • Number of events 2 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.4%
1/29 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/29 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.6%
1/28 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
6.9%
2/29 • Number of events 2 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/29 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
7.1%
2/28 • Number of events 2 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.4%
1/29 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
General disorders
Fatigue
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.4%
1/29 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/29 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
3/30 • Number of events 3 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
6.9%
2/29 • Number of events 2 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.6%
1/28 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.4%
1/29 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.4%
1/29 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.4%
1/29 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
10.3%
3/29 • Number of events 3 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
17.2%
5/29 • Number of events 5 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/30 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
3.4%
1/29 • Number of events 1 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
0.00%
0/28 • Baseline to end of follow-up (up to 35 days)
All participants from the safety population. Adverse events were reported by treatment period: Day 1 (Orforglipron alone, including Days 2-5 observation period), Days 6-18 except Day 15 (Carbamazepine alone, including Days 19-35 follow-up), and Day 15 (Orforglipron + Carbamazepine combination).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60