parallel randomized trial

NCT04855292

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Phase Ib Study in Overweight/Obese Subjects Without Diabetes to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of TG103 Injection

Overweight or obesity without diabetes (adults)NCT04855292S003063

Design

Randomized: 48
Start year: 2021
Treatment: 12 weeks, follow-up 14 weeks
Countries: China (3 sites)
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. (industry)
Eligibility: age 18 to 75; BMI 26 or more; weight 60 kg or more; HbA1c below 6.5; no diabetes

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	TG103 15 mg injection once weekly TG103 15.0 mg	lifestyle: none	12	12
A2	TG103 22.5 mg injection once weekly TG103 22.5 mg	lifestyle: none	12	12
A3	TG103 30 mg injection once weekly TG103 30.0 mg	lifestyle: none	12	12
A4	Placebo Pooled placebo	lifestyle: none	12	12

Baseline characteristics

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

Characteristic	Statistic	TG103 15 mg injection once weekly A1	TG103 22.5 mg injection once weekly A2	TG103 30 mg injection once weekly A3	Placebo A4
age	mean (years)	33.3	28.8	38.8	34.5
age	sd (years)	8.0	7.6	11.8	10.6
bmi	mean (kg/m2)	29.0	30.4	30.3	29.4
bmi	sd (kg/m2)	2.4	3.1	2.6	1.9
female	n	4	3	6	5
female	percent	33.3	25.0	50.0	41.7
sbp	mean (mmHg)	115.9	119.9	124.1	115.5
sbp	sd (mmHg)	14.9	14.9	16.5	10.2
waist	mean (cm)	98.38	100.38	97.36	95.78
waist	sd (cm)	5.30	8.99	7.18	8.62
weight	mean (kg)	79.68	85.77	81.03	80.07
weight	sd (kg)	6.86	12.97	10.43	10.96

Analyses this trial contributes to

Results

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

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-0.3 mmHg	11.8	12	not stated; modified itt; R0022276:Table 4
12	A2	change	-5.6 mmHg	10.5	12	not stated; modified itt; R0022276:Table 4
12	A3	change	-16.1 mmHg	7.9	12	not stated; modified itt; R0022276:Table 4
12	A4	change	2.5 mmHg	12.7	12	not stated; modified itt; R0022276:Table 4

Percent body weight change (7 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	percent change	-7.24 percent	0.97		12	not stated; modified itt; R0022276:Table 4
12	A1 vs A4	md	-5.48 percent		-8.77 to -2.19		not stated; modified itt; R0022276:Table 4
12	A2	percent change	-5.79 percent	1.05		12	not stated; modified itt; R0022276:Table 4
12	A2 vs A4	md	-4.03 percent		-7.51 to -0.55		not stated; modified itt; R0022276:Table 4
12	A3	percent change	-6.47 percent	1.02		12	not stated; modified itt; R0022276:Table 4
12	A3 vs A4	md	-4.71 percent		-8.08 to -1.33		not stated; modified itt; R0022276:Table 4
12	A4	percent change	-1.76 percent	0.93		12	not stated; modified itt; R0022276:Table 4

Weight loss of 5 percent or more (7 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	responders			8 / 12	not stated; modified itt; R0022276:Table 4
12	A1 vs A4	or	33.73	2.78 to 408.63		not stated; modified itt; R0022276:Results
12	A2	responders			5 / 12	not stated; modified itt; R0022276:Table 4
12	A2 vs A4	or	8.93	0.78 to 102.43		not stated; modified itt; R0022276:Results
12	A3	responders			6 / 12	not stated; modified itt; R0022276:Table 4
12	A3 vs A4	or	19.14	1.62 to 226.56		not stated; modified itt; R0022276:Results
12	A4	responders			1 / 12	not stated; modified itt; R0022276:Table 4

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; R0022276:Results
A2	events	0 / 12	not stated; safety; R0022276:Results
A3	events	0 / 12	not stated; safety; R0022276:Results
A4	events	0 / 12	not stated; safety; R0022276:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; R0022276:Results
A2	events	0 / 12	not stated; safety; R0022276:Results
A3	events	0 / 12	not stated; safety; R0022276:Results
A4	events	0 / 12	not stated; safety; R0022276:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; R0022276:Results
A2	events	0 / 12	not stated; safety; R0022276:Results
A3	events	0 / 12	not stated; safety; R0022276:Results
A4	events	0 / 12	not stated; safety; R0022276:Results

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	4 / 12	not stated; safety; R0022276:Table 2
A2	events	8 / 12	not stated; safety; R0022276:Table 2
A3	events	8 / 12	not stated; safety; R0022276:Table 2
A4	events	0 / 12	not stated; safety; R0022276:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	3 / 12	not stated; safety; R0022276:Table 2
A2	events	4 / 12	not stated; safety; R0022276:Table 2
A3	events	5 / 12	not stated; safety; R0022276:Table 2
A4	events	0 / 12	not stated; safety; R0022276:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	4 / 12	not stated; safety; R0022276:Table 2
A2	events	6 / 12	not stated; safety; R0022276:Table 2
A3	events	9 / 12	not stated; safety; R0022276:Table 2
A4	events	1 / 12	not stated; safety; R0022276:Table 2

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; safety; R0022276:Results
A2	events	0 / 12	not stated; safety; R0022276:Results
A3	events	0 / 12	not stated; safety; R0022276:Results
A4	events	0 / 12	not stated; safety; R0022276:Results