Table 3. Summary of TEAEs (All Causality)a.
| Measurement | No. (%) | ||||||
|---|---|---|---|---|---|---|---|
| Placebo (n = 66) | Danuglipron | Total (N = 411) | |||||
| 2.5 mg Twice daily (n = 68) | 10 mg Twice daily (n = 68) | 40 mg Twice daily (n = 71) | 80 mg Twice daily (n = 67) | 120 mg Twice daily (n = 71) | |||
| No. of TEAEs | 45 | 74 | 75 | 93 | 122 | 129 | 538 |
| Mild | 35 | 54 | 54 | 66 | 70 | 86 | 365 |
| Moderate | 9 | 17 | 20 | 21 | 47 | 40 | 154 |
| Severe | 1 | 3 | 1 | 6 | 5 | 3 | 19 |
| Participants with ≥1 TEAE | |||||||
| Any TEAE | 32 (48) | 32 (47) | 31 (46) | 42 (59) | 43 (64) | 44 (62) | 224 (55) |
| Serious TEAE | 1 (2) | 1 (1) | 2 (3) | 6 (8) | 2 (3) | 1 (1) | 13 (3) |
| Severe TEAE | 1 (2) | 2 (3) | 1 (1) | 5 (7) | 3 (4) | 1 (1) | 13 (3) |
| Discontinued study medication because of TEAEb | 5 (8) | 2 (3) | 3 (4) | 8 (11) | 15 (22) | 24 (34) | 57 (14) |
| Discontinued study medication because of TEAE but continued studyc | 4 (6) | 1 (1) | 3 (4) | 6 (8) | 12 (18) | 19 (27) | 45 (11) |
| Discontinued study because of TEAEd | 1 (2) | 1 (1) | 0 | 3 (4) | 3 (4) | 4 (6) | 12 (3) |
| Participants with gastrointestinal disorder TEAEe | 5 (8) | 13 (19) | 12 (18) | 22 (31) | 33 (49) | 35 (49) | 120 (29) |
| Participants with TEAE (all preferred terms with ≥5% in any treatment group) | |||||||
| Nausea | 2 (3) | 5 (7) | 5 (7) | 11 (15) | 22 (33) | 23 (32) | 68 (17) |
| Diarrhea | 2 (3) | 3 (4) | 4 (6) | 8 (11) | 12 (18) | 7 (10) | 36 (9) |
| Vomiting | 0 | 0 | 1 (1) | 5 (7) | 11 (16) | 18 (25) | 35 (9) |
| Headache | 4 (6) | 4 (6) | 1 (1) | 5 (7) | 2 (3) | 7 (10) | 23 (6) |
| Dyspepsia | 0 | 4 (6) | 3 (4) | 2 (3) | 9 (13) | 2 (3) | 20 (5) |
| Hypoglycemiaf | 0 | 1 (1) | 1 (1) | 4 (6) | 6 (9) | 3 (4) | 15 (4) |
| Dizziness | 1 (2) | 1 (1) | 4 (6) | 3 (4) | 1 (1) | 5 (7) | 15 (4) |
| Gastroesophageal reflux disease | 0 | 1 (1) | 2 (3) | 2 (3) | 4 (6) | 5 (7) | 14 (3) |
| SARS-CoV-2 test result positive | 2 (3) | 4 (6) | 3 (4) | 3 (4) | 1 (1) | 1 (1) | 14 (3) |
| Hyperglycemia | 6 (9) | 2 (3) | 1 (1) | 0 | 4 (6) | 0 | 13 (3) |
| Abdominal distension | 1 (2) | 0 | 1 (1) | 4 (6) | 3 (4) | 2 (3) | 11 (3) |
| Decreased appetite | 0 | 2 (3) | 0 | 2 (3) | 1 (1) | 5 (7) | 10 (2) |
| Urinary tract infection | 0 | 1 (1) | 0 | 5 (7) | 3 (4) | 1 (1) | 10 (2) |
| Hypertension | 0 | 1 (1) | 3 (4) | 1 (1) | 4 (6) | 1 (1) | 10 (2) |
Abbreviation: TEAE, treatment-emergent adverse event.
Safety analysis set. Except for number of TEAEs, data are number (percentage) of participants, and participants are counted only once per treatment in each row. The table includes all data collected since the first dose of double-blind study medication. Preferred terms are based on Medical Dictionary for Regulatory Activities, version 24.0 coding dictionary.
Participants who discontinued study medication might still have continued in the study.
Participants with record of a TEAE indicating that the action taken was to withdraw study medication but the TEAE did not cause them to discontinue from the study.
Participants with record of a TEAE indicating the TEAE caused them to be discontinued from the study.
TEAEs with 2 or more occurrences in any treatment group.
These reports of TEAEs of hypoglycemia did not necessarily meet the criteria for protocol-defined hypoglycemic events (eTable 1 in Supplement 2).