Table 3.

Adverse events

	Part 1		Part 2		Combined
	Placebo (n = 11)	TTP399 (n = 9)	Placebo (n = 45)	TTP399 (n = 40)	Placebo (n = 56)	TTP399 (n = 49)
AEs reported	16	13	83	58	99	71
Participants with at least one AE	7 (64)	6 (67)	29 (64)	26 (65)	36 (64)	32 (65)
SAEs	0	0	1	1	1	1
Participants with at least 1 SAE	0	0	1 (2)	1 (2)	1 (2)	1 (2)
Coronary artery disease	0	0	1 (2)	0	1 (2)	0
Noncardiac chest pain	0	0	0	1 (2)	0	1 (2)
Participants with AE leading to death	0	0	0	0	0	0
Participants with at least one drug-related AE	2 (18)	1 (11)	3 (7)	2 (5)	5 (9)	3 (6)
Hypoglycemia*
Participants with hypoglycemic AEs (week 1 to EOS)	0	0	9 (20)	5 (12)	9 (16)	5 (10)
Total hypoglycemic AEs (weeks 1–12)	0	0	27	12	27	12
Severe hypoglycemia	0	0	1	0	1	0
Symptomatic hypoglycemia	0	0	26	12	26	12
Events per person-exposure month	0	0	0.2	0.1
Participants with hypoglycemic AEs (week 2 to EOS)	0	0	8 (18)	2 (5)	8 (14)	2 (4)
Events per person-exposure month	0	0	0.15	0.04	0.15	0.04
Ketone events*
DKA AEs	0	0	0	0	0	0
Ketosis AEs	0	0	1	1	1	1
Participants with at least one elevated serum BOHB level	3 (27)	0	11 (24)	5 (13)	14 (25)	5 (10)
>1 mmol/L	0	0	3 (7)	1 (3)	3 (5)	1 (2)
>0.4 and ≤1 mmol/L	3 (27)	0	8 (18)	4 (10)	11 (20)	4 (8)
Participants with change from baseline ≥1 mmol/L	0	0	2 (4)	0	2 (4)	0
Liver function*
ALT, AST, ALP >1.5× ULN and/or bilirubin >2× ULN	0	0	2 (4)	1 (2)	2 (4)	1 (2)
AST or ALT >3× ULN and bilirubin >1.5× ULN	0	0	0	0	0	0

Data presented as n or n (%). Population includes any person randomly assigned at study start. Severe hypoglycemia was defined as the participant having blood glucose <49 mg/dL and neurologic impairment requiring assistance to actively administer carbohydrate, glucagon, or other resuscitative actions. If blood glucose was not measured, the clinical manifestations must have been reversed by oral carbohydrate, subcutaneous glucagon, or intravenous glucose. ALP, alkaline phosphatase; BOHB, β-hydroxybutyrate; EOS, end of study; SAE, significant AE; ULN, upper limit of normal.

^*AE of special interest.