parallel randomized trial

NCT04838405

A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients With Type 2 Diabetes Mellitus

Overweight or obesity without diabetes (adults)NCT04838405S002824

Design

Randomized
Start year: 2021
Treatment: 4 weeks, follow-up 6 weeks
Countries: Australia, Mexico (2 sites)
Sponsor: Carmot Therapeutics (industry)
Eligibility: age 18 to 65, BMI 25 or more (30 or more in cohorts 7 and 8), no diabetes

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized
A1	Placebo SAD pooled placebo	lifestyle: not reported	10
A10	CT-388 CT-388 5/8/12/12 mg weekly	lifestyle: not reported	6
A2	CT-388 0.5 mg injection CT-388 0.5 mg single dose	lifestyle: not reported	6
A3	CT-388 2.0 mg injection CT-388 2.0 mg single dose	lifestyle: not reported	6
A4	CT-388 5.0 mg injection CT-388 5.0 mg single dose	lifestyle: not reported	6
A5	CT-388 6.0 mg injection CT-388 6.0 mg single dose	lifestyle: not reported	6
A6	CT-388 7.5 mg injection CT-388 7.5 mg single dose	lifestyle: not reported	6
A7	Placebo MAD pooled placebo	lifestyle: not reported	6
A8	CT-388 7.5 mg injection once weekly CT-388 5/5/5/7.5 mg weekly	lifestyle: not reported	6
A9	CT-388 CT-388 5/5/8/12 mg weekly	lifestyle: not reported	6

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	CT-388 0.5 mg injection A2	CT-388 2.0 mg injection A3	CT-388 5.0 mg injection A4	CT-388 6.0 mg injection A5	CT-388 7.5 mg injection A6	Placebo A7	CT-388 7.5 mg injection once weekly A8	CT-388 5/5/8/12 mg weekly A9	CT-388 5/8/12/12 mg weekly A10
age	mean (years)	36.6	35.5	34.8	40.8	37.3	29.7	41.5	34.0	34.3	26.3
age	sd (years)	13.2	12.5	14.6	11.6	10.1	11.0	10.7	10.9	14.0	7.9
asian	n	1	0	0	1	2	1
asian	percent	10.0			16.7	33.3	16.7
bmi	mean (kg/m2)	32.2	30.2	33.9	31.4	33.4	28.3	34.0	31.3	35.6	34.8
bmi	sd (kg/m2)	2.9	2.3	3.6	4.2	4.8	3.4	1.1	3.8	2.8	4.0
female	n	6	5	5	3	1	4	4	5	1	2
female	percent	60.0	83.3	83.3	50.0	16.7	66.7	66.7	83.3	16.7	33.3
hba1c	max (percent)							5.8	5.6	5.8	5.5
hba1c	median (percent)							5.5	5.2	5.3	5.4
hba1c	min (percent)							4.9	4.9	4.7	5.1
hispanic	n	0	0	0	0	0	0	6	6	6	6
hispanic	percent							100	100	100	100
other race other	n	1	2	0	0	0	0	6	6	6	6
other race other	percent	10.0	33.3					100	100	100	100
weight	mean (kg)	95.6	81.5	96.6	94.9	109.4	79.0	90.1	81.8	107.2	97.1
weight	sd (kg)	16.9	6.2	20.3	25.5	24.6	12.2	14.1	16.7	19.3	18.9
white	n	8	4	6	5	4	5
white	percent	80.0	66.7	100	83.3	66.7	83.3

Analyses this trial contributes to

Results

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

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Detail
4	A10	change	-5.7 mmHg	18.3	not stated; other; R0007991:Results
4	A7	change	-0.3 mmHg	12.6	not stated; other; R0007991:Results
4	A9	change	-9.3 mmHg	9.0	not stated; other; R0007991:Results

Percent body weight change (4 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Detail
4	A10 vs A7	md	-7.5 percent	-9.81 to -5.25	not stated; other; R0007991:Results
4	A7	percent change	-0.5 percent		not stated; other; R0007991:Abstract
4	A8 vs A7	md	-4.1 percent	-6.37 to -1.80	not stated; other; R0007991:Results
4	A9 vs A7	md	-5.6 percent	-7.93 to -3.28	not stated; other; R0007991:Results

All cause mortality (10 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; randomized; R0007991:Table 2
A10	events	0 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	0 / 6	not stated; randomized; R0007991:Table 2
A4	events	0 / 6	not stated; randomized; R0007991:Table 2
A5	events	0 / 6	not stated; randomized; R0007991:Table 2
A6	events	0 / 6	not stated; randomized; R0007991:Table 2
A7	events	0 / 6	not stated; randomized; R0007991:Table 3
A8	events	0 / 6	not stated; randomized; R0007991:Table 3
A9	events	0 / 6	not stated; randomized; R0007991:Table 3

Serious adverse events (10 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; randomized; R0007991:Table 2
A10	events	0 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	0 / 6	not stated; randomized; R0007991:Table 2
A4	events	0 / 6	not stated; randomized; R0007991:Table 2
A5	events	1 / 6	not stated; randomized; R0007991:Table 2
A6	events	1 / 6	not stated; randomized; R0007991:Table 2
A7	events	0 / 6	not stated; randomized; R0007991:Table 3
A8	events	0 / 6	not stated; randomized; R0007991:Table 3
A9	events	0 / 6	not stated; randomized; R0007991:Table 3

Discontinuation due to adverse events (10 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; randomized; R0007991:Table 2
A10	events	0 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	0 / 6	not stated; randomized; R0007991:Table 2
A4	events	0 / 6	not stated; randomized; R0007991:Table 2
A5	events	1 / 6	not stated; randomized; R0007991:Table 2
A6	events	0 / 6	not stated; randomized; R0007991:Table 2
A7	events	0 / 6	not stated; randomized; R0007991:Table 3
A8	events	0 / 6	not stated; randomized; R0007991:Table 3
A9	events	0 / 6	not stated; randomized; R0007991:Table 3

Nausea (10 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 10	not stated; randomized; R0007991:Table 2
A10	events	3 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	0 / 6	not stated; randomized; R0007991:Table 2
A4	events	0 / 6	not stated; randomized; R0007991:Table 2
A5	events	1 / 6	not stated; randomized; R0007991:Table 2
A6	events	5 / 6	not stated; randomized; R0007991:Table 2
A7	events	1 / 6	not stated; randomized; R0007991:Table 3
A8	events	6 / 6	not stated; randomized; R0007991:Table 3
A9	events	1 / 6	not stated; randomized; R0007991:Table 3

Vomiting (10 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; randomized; R0007991:Table 2
A10	events	2 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	0 / 6	not stated; randomized; R0007991:Table 2
A4	events	2 / 6	not stated; randomized; R0007991:Table 2
A5	events	2 / 6	not stated; randomized; R0007991:Table 2
A6	events	3 / 6	not stated; randomized; R0007991:Table 2
A7	events	0 / 6	not stated; randomized; R0007991:Table 3
A8	events	5 / 6	not stated; randomized; R0007991:Table 3
A9	events	2 / 6	not stated; randomized; R0007991:Table 3

Diarrhea (10 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	1 / 10	not stated; randomized; R0007991:Table 2
A10	events	3 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	1 / 6	not stated; randomized; R0007991:Table 2
A4	events	0 / 6	not stated; randomized; R0007991:Table 2
A5	events	1 / 6	not stated; randomized; R0007991:Table 2
A6	events	3 / 6	not stated; randomized; R0007991:Table 2
A7	events	3 / 6	not stated; randomized; R0007991:Table 3
A8	events	2 / 6	not stated; randomized; R0007991:Table 3
A9	events	2 / 6	not stated; randomized; R0007991:Table 3

Constipation (10 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	2 / 10	not stated; randomized; R0007991:Table 2
A10	events	1 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	1 / 6	not stated; randomized; R0007991:Table 2
A4	events	0 / 6	not stated; randomized; R0007991:Table 2
A5	events	0 / 6	not stated; randomized; R0007991:Table 2
A6	events	0 / 6	not stated; randomized; R0007991:Table 2
A7	events	0 / 6	not stated; randomized; R0007991:Table 3
A8	events	3 / 6	not stated; randomized; R0007991:Table 3
A9	events	0 / 6	not stated; randomized; R0007991:Table 3

Discontinuation due to gastrointestinal adverse events (10 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 10	not stated; randomized; R0007991:Table 2
A10	events	0 / 6	not stated; randomized; R0007991:Table 3
A2	events	0 / 6	not stated; randomized; R0007991:Table 2
A3	events	0 / 6	not stated; randomized; R0007991:Table 2
A4	events	0 / 6	not stated; randomized; R0007991:Table 2
A5	events	1 / 6	not stated; randomized; R0007991:Table 2
A6	events	0 / 6	not stated; randomized; R0007991:Table 2
A7	events	0 / 6	not stated; randomized; R0007991:Table 3
A8	events	0 / 6	not stated; randomized; R0007991:Table 3
A9	events	0 / 6	not stated; randomized; R0007991:Table 3