parallel randomized trial

NCT05110846

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT05110846S003276

Design

Randomized: 103
Start year: 2022
Treatment: 26 weeks, follow-up 30 weeks
Countries: Mexico (5 sites)
Sponsor: Carmot Therapeutics, Inc. (industry)
Eligibility: age 18 to 75; HbA1c 7.0 to 10.0; BMI 27 or more; diet and exercise or stable metformin

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	CT-868 CT-868 1.75 mg	diet and exercise or stable metformin; lifestyle: not reported	25	25
A2	CT-868 CT-868 4.0 mg	diet and exercise or stable metformin; lifestyle: not reported	51
A3	Placebo Placebo	diet and exercise or stable metformin; lifestyle: not reported	27	27

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	CT-868 1.75 mg A1	CT-868 4.0 mg A2	Placebo A3	Whole trial ALL
age group:final_dose_1.75mg	mean (years)	52.3
age group:final_dose_1.75mg	sd (years)	7.83
age group:final_dose_3.25mg	mean (years)		48.2
age group:final_dose_3.25mg	sd (years)		9.90
age group:final_dose_4.0mg	mean (years)		49.0
age group:final_dose_4.0mg	sd (years)		12.14
age	mean (years)			50.3
age	sd (years)			11.66
bmi group:final_dose_1.75mg	mean (kg/m2)	36.0
bmi group:final_dose_1.75mg	sd (kg/m2)	6.61
bmi group:final_dose_3.25mg	mean (kg/m2)		34.8
bmi group:final_dose_3.25mg	sd (kg/m2)		4.53
bmi group:final_dose_4.0mg	mean (kg/m2)		34.8
bmi group:final_dose_4.0mg	sd (kg/m2)		5.50
bmi	mean (kg/m2)			35.7
bmi	sd (kg/m2)			6.31
egfr group:final_dose_1.75mg	mean (mL/min/1.73 m2)	93.4
egfr group:final_dose_1.75mg	sd (mL/min/1.73 m2)	13.49
egfr group:final_dose_3.25mg	mean (mL/min/1.73 m2)		104.1
egfr group:final_dose_3.25mg	sd (mL/min/1.73 m2)		12.92
egfr group:final_dose_4.0mg	mean (mL/min/1.73 m2)		102.7
egfr group:final_dose_4.0mg	sd (mL/min/1.73 m2)		15.03
egfr	mean (mL/min/1.73 m2)			99.8
egfr	sd (mL/min/1.73 m2)			15.26
female group:final_dose_1.75mg	n	14
female group:final_dose_1.75mg	percent	53.8
female group:final_dose_3.25mg	n		12
female group:final_dose_3.25mg	percent		66.7
female group:final_dose_4.0mg	n		22
female group:final_dose_4.0mg	percent		68.8
female	n			16
female	percent			59.3
hba1c group:final_dose_1.75mg	mean (percent)	8.27
hba1c group:final_dose_1.75mg	sd (percent)	0.84
hba1c group:final_dose_3.25mg	mean (percent)		7.58
hba1c group:final_dose_3.25mg	sd (percent)		0.97
hba1c group:final_dose_4.0mg	mean (percent)		8.36
hba1c group:final_dose_4.0mg	sd (percent)		0.74
hba1c	mean (percent)			8.05
hba1c	sd (percent)			0.96
hispanic group:final_dose_1.75mg	n	26
hispanic group:final_dose_1.75mg	percent	100.0
hispanic group:final_dose_3.25mg	n		18
hispanic group:final_dose_3.25mg	percent		100.0
hispanic group:final_dose_4.0mg	n		32
hispanic group:final_dose_4.0mg	percent		100.0
hispanic	n			27
hispanic	percent			100.0
metformin use	percent				100
sbp group:final_dose_1.75mg	mean (mmHg)	126.2
sbp group:final_dose_1.75mg	sd (mmHg)	6.87
sbp group:final_dose_3.25mg	mean (mmHg)		123.8
sbp group:final_dose_3.25mg	sd (mmHg)		13.30
sbp group:final_dose_4.0mg	mean (mmHg)		123.3
sbp group:final_dose_4.0mg	sd (mmHg)		12.93
sbp	mean (mmHg)			122.9
sbp	sd (mmHg)			14.10
weight group:final_dose_1.75mg	mean (kg)	92.3
weight group:final_dose_1.75mg	sd (kg)	20.52
weight group:final_dose_3.25mg	mean (kg)		90.1
weight group:final_dose_3.25mg	sd (kg)		16.42
weight group:final_dose_4.0mg	mean (kg)		90.6
weight group:final_dose_4.0mg	sd (kg)		17.42
weight	mean (kg)			94.6
weight	sd (kg)			21.32

Results

60 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (11 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.50 percent			25	not stated; modified itt; group:final_dose_1.75mg; R0029622:Figure 2
26	A1 vs A3	md	-1.91 percent		-2.63 to -1.18		not stated; modified itt; group:final_dose_1.75mg; R0029622:Table 1
26	A1	change	-1.48 percent	0.26		25	not stated; modified itt; group:final_dose_1.75mg; R0029622:Table 1
26	A2	change	-1.16 percent			18	not stated; modified itt; group:final_dose_3.25mg; R0029622:Figure 2
26	A2 vs A3	md	-1.61 percent		-2.40 to -0.82		not stated; modified itt; group:final_dose_3.25mg; R0029622:Table 1
26	A2	change	-1.84 percent			32	not stated; modified itt; group:final_dose_4.0mg; R0029622:Figure 2
26	A2	change	-1.81 percent	0.23		32	not stated; modified itt; group:final_dose_4.0mg; R0029622:Table 1
26	A2 vs A3	md	-2.24 percent		-2.93 to -1.56		not stated; modified itt; group:final_dose_4.0mg; R0029622:Table 1
26	A2	change	-1.18 percent	0.31		18	not stated; modified itt; group:final_dose_3.25mg; R0029622:Table 1
26	A3	change	0.43 percent	0.26		27	not stated; modified itt; R0029622:Table 1
26	A3	change	0.42 percent			27	not stated; modified itt; R0029622:Figure 2

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	52.0	25	not stated; modified itt; group:final_dose_1.75mg; R0029622:Figure 2
26	A2	responders	77.8	18	not stated; modified itt; group:final_dose_3.25mg; R0029622:Figure 2
26	A2	responders	75.0	32	not stated; modified itt; group:final_dose_4.0mg; R0029622:Figure 2
26	A3	responders	24.0	27	not stated; modified itt; R0029622:Figure 2

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Results
A2	events	0 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Results
A2	events	0 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Results
A3	events	0 / 27	not stated; safety; R0029622:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	3.3 mmHg	12.35	26	not stated; safety; group:final_dose_1.75mg; R0029622:Results
26	A2	change	-7.6 mmHg	13.88	18	not stated; safety; group:final_dose_3.25mg; R0029622:Results
26	A2	change	-7.1 mmHg	11.44	32	not stated; safety; group:final_dose_4.0mg; R0029622:Results
26	A3	change	1.0 mmHg	10.81	27	not stated; safety; R0029622:Results

Percent body weight change (7 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	percent change	-2.8 percent		25	not stated; modified itt; group:final_dose_1.75mg; R0029622:Figure 3
26	A2	percent change	-5.4 percent	0.50	32	not stated; modified itt; group:final_dose_4.0mg; R0029622:Results
26	A2	percent change	-3.0 percent		18	not stated; modified itt; group:final_dose_3.25mg; R0029622:Figure 3
26	A2	percent change	-5.5 percent		32	not stated; modified itt; group:final_dose_4.0mg; R0029622:Figure 3
26	A2 vs A3	md	-2.9 percent			not stated; modified itt; group:final_dose_4.0mg; R0029622:Abstract
26	A3	percent change	-2.5 percent	0.58	27	not stated; modified itt; R0029622:Results
26	A3	percent change	-2.3 percent		27	not stated; modified itt; R0029622:Figure 3

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A2	responders				15 / 29	not stated; other; group:final_dose_4.0mg; R0029622:Results
26	A3	responders				5 / 22	not stated; other; R0029622:Results

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Table 2
A2	events	0 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Table 2
A2	events	0 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Table 2
A3	events	0 / 27	not stated; safety; R0029622:Table 2

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Table 2
A2	events	0 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Table 2
A2	events	0 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Table 2
A3	events	0 / 27	not stated; safety; R0029622:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Table 2
A2	events	0 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Table 2
A2	events	0 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Table 2
A3	events	1 / 27	not stated; safety; R0029622:Table 2

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	5 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Table 2
A2	events	2 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Table 2
A2	events	11 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Table 2
A3	events	7 / 27	not stated; safety; R0029622:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	3 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Table 2
A2	events	2 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Table 2
A2	events	2 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Table 2
A3	events	1 / 27	not stated; safety; R0029622:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	12 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Table 2
A2	events	4 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Table 2
A2	events	14 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Table 2
A3	events	6 / 27	not stated; safety; R0029622:Table 2

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	2 / 26	not stated; safety; group:final_dose_1.75mg; R0029622:Table 2
A2	events	10 / 32	not stated; safety; group:final_dose_4.0mg; R0029622:Table 2
A2	events	0 / 18	not stated; safety; group:final_dose_3.25mg; R0029622:Table 2
A3	events	5 / 27	not stated; safety; R0029622:Table 2