Table 2 Summary of TEAEs (safety analysis set)

From: TERN-501 monotherapy and combination therapy with TERN-101 in metabolic dysfunction-associated steatohepatitis: the randomized phase 2a DUET trial

AE category

AE, n (%)

Placebo

(N = 24)

TERN-501

1 mg

(N = 23)

TERN-501

3 mg

(N = 23)

TERN-501

6 mg

(N = 22)

TERN-101

10 mg

(N = 24)

TERN-501

3 mg

 + TERN-101

10 mg (N = 23)

TERN-501

6 mg

 + TERN-101

10 mg (N = 23)

Total

(N = 162)

Any TEAE

11 (45.8)

11 (47.8)

13 (56.5)

11 (50.0)

10 (41.7)

14 (60.9)

12 (52.2)

82 (50.6)

≥Grade 3 severitya

0

1 (4.3)

0

0

1 (4.2)

0

0

2 (1.2)

Any serious TEAE

0

1 (4.3)

0

0

2 (8.3)

0

0

3 (1.9)

Leading to death

0

0

0

0

0

0

0

0

Leading to study drug interruption

1 (4.2)

1 (4.3)

0

1 (4.5)

1 (4.2)

1 (4.3)

0

5 (3.1)

Leading to study drug discontinuation

1 (4.2)

0

1 (4.3)

1 (4.5)

0

1 (4.3)

1 (4.3)

5 (3.1)

Leading to discontinuation from the study

0

0

0

0

0

0

0

0

Any TEAE by maximum gradea

Grade 1

7 (29.2)

7 (30.4)

6 (26.1)

6 (27.3)

3 (12.5)

8 (34.8)

11 (47.8)

48 (29.6)

Grade 2

4 (16.7)

3 (13.0)

7 (30.4)

5 (22.7)

6 (25.0)

6 (26.1)

1 (4.3)

32 (19.8)

Grade 3

0

1 (4.3)

0

0

1 (4.2)

0

0

2 (1.2)

Grade 4

0

0

0

0

0

0

0

0

Grade 5

0

0

0

0

0

0

0

0

Any study treatment-related TEAE

5 (20.8)

1 (4.3)

4 (17.4)

4 (18.2)

2 (8.3)

6 (26.1)

4 (17.4)

26 (16.0)

≥Grade 3 severity

0

0

0

0

0

0

0

0

Any serious TEAE

0

0

0

0

0

0

0

0

  1. A TEAE is any AE with a start date on or after the date of first administration of study drug up until 30 days after the last administration of study drug or through the follow-up period (week 16).
  2. aAEs were assigned a severity grade using the Common Terminology Criteria for Adverse Events v.5.0. Medical Dictionary for Regulatory Activities v.25.1.
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