parallel randomized trial

NCT06256536

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients

Overweight or obesity without diabetes (adults)NCT06256536S002782

Design

Randomized: 60
Start year: 2022
Treatment: 35 weeks, follow-up 38 weeks
Countries: China (4 sites)
Sponsor: Gan and Lee Pharmaceuticals (industry)
Eligibility: age 18 to 65; Part A BMI 28 or more, or 24 to 28 with a condition; Part B BMI 28 or more; no diabetes

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	GZR18 (bofanglutide) Part A GZR18 4.8 mg weekly	lifestyle: standard	18	18
A2	Placebo Part A placebo	lifestyle: standard	6	6
A3	GZR18 (bofanglutide) Part B GZR18 up to 30 mg, weekly or every 2 weeks	lifestyle: standard	27	26
A4	Placebo Part B placebo	lifestyle: standard	9	9

Baseline characteristics

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

Characteristic	Statistic	Part A GZR18 4.8 mg weekly A1	Placebo A2	Part B GZR18 up to 30 mg, weekly or every 2 weeks A3	Placebo A4
age	mean (years)	34.2	31.5	35.2	40.1
age	sd (years)	9.68	6.41	8.79	9.92
bmi	mean (kg/m2)	33.92	31.92	33.63	33.92
bmi	sd (kg/m2)	4.15	1.77	3.92	4.29
female	n	10	2	14	4
female	percent	55.6	33.3	53.8	44.4
other ethnicity han	n	16	6	25	9
other ethnicity han	percent	88.9	100	96.2	100
sbp	mean (mmHg)	122.40	125.80	122.50	122.60
sbp	sd (mmHg)	11.98	6.91	9.53	8.56
waist	mean (cm)	107.86	106.5	106.83	104.68
waist	sd (cm)	9.52	7.82	12.64	10.50
weight	mean (kg)	98.67	95.77	95.07	94.74
weight	sd (kg)	14.69	13.11	18.34	16.50

Results

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

Systolic blood pressure change (8 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	-7.30 mmHg		18	not stated; full analysis; R0002818:Supplement Table S2
26	A1 vs A2	md	-7.80 mmHg	-22.60 to 6.90		not stated; full analysis; R0002818:Supplement Table S2
26	A2	change	0.50 mmHg		6	not stated; full analysis; R0002818:Supplement Table S2
35	A3 vs A4	md	-10.3 mmHg	-22.4 to 1.9		not stated; full analysis; group:qw; R0002818:Figure 4D
35	A3	change	-13.0 mmHg		16	not stated; full analysis; group:qw; R0002818:Results
35	A3	change	-11.4 mmHg		10	not stated; full analysis; group:q2w; R0002818:Results
35	A3 vs A4	md	-8.7 mmHg	-21.6 to 4.2		not stated; full analysis; group:q2w; R0002818:Figure 4D
35	A4	change	-2.8 mmHg		9	not stated; full analysis; R0002818:Results

Percent body weight change (8 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1 vs A2	md	-16.1 percent	-26.4 to -5.7		not stated; full analysis; R0002818:Results
26	A1	percent change	-9.36 percent		18	not stated; full analysis; R0002818:Results
26	A2	percent change	6.68 percent		6	not stated; full analysis; R0002818:Results
35	A3	percent change	-17.8 percent		16	not stated; full analysis; group:qw; R0002818:Results
35	A3 vs A4	md	-18.6 percent	-25.5 to -11.6		not stated; full analysis; group:qw; R0002818:Results
35	A3	percent change	-12.8 percent		10	not stated; full analysis; group:q2w; R0002818:Results
35	A3 vs A4	md	-13.5 percent	-21.0 to -6.0		not stated; full analysis; group:q2w; R0002818:Results
35	A4	percent change	0.7 percent		9	not stated; full analysis; R0002818:Results

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

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	66.7	18	not stated; full analysis; R0002818:Results
26	A2	responders		0 / 6	not stated; full analysis; R0002818:Results
35	A3	responders	71.4	7	not stated; completers; group:q2w; R0002818:Results
35	A3	responders	100	10	not stated; completers; group:qw; R0002818:Results
35	A4	responders		0 / 5	not stated; completers; R0002818:Results

Weight loss of 10 percent or more (3 lines; O11B)

Week	Arm	Statistic	Estimate	Events / N	Detail
35	A3	responders	71.4	7	not stated; completers; group:q2w; R0002818:Results
35	A3	responders	90	10	not stated; completers; group:qw; R0002818:Results
35	A4	responders	0	5	not stated; completers; R0002818:Figure 3C

Weight loss of 15 percent or more (3 lines; O11C)

Week	Arm	Statistic	Estimate	Events / N	Detail
35	A3	responders	42.9	7	not stated; completers; group:q2w; R0002818:Results
35	A3	responders	80	10	not stated; completers; group:qw; R0002818:Results
35	A4	responders	0	5	not stated; completers; R0002818:Figure 3C

Weight loss of 20 percent or more (3 lines; O11D)

Week	Arm	Statistic	Estimate	Events / N	Detail
35	A3	responders	14.3	7	not stated; completers; group:q2w; R0002818:Results
35	A3	responders	40	10	not stated; completers; group:qw; R0002818:Results
35	A4	responders	0	5	not stated; completers; R0002818:Figure 3C

All cause mortality (6 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; safety; R0002818:Table 2
A2	events	0 / 6	not stated; safety; R0002818:Table 2
A3	events	0 / 10	not stated; safety; group:q2w; R0002818:Table 2
A3	events	0 / 26	not stated; safety; R0002818:Results
A3	events	0 / 16	not stated; safety; group:qw; R0002818:Table 2
A4	events	0 / 9	not stated; safety; R0002818:Table 2

Hospitalization for heart failure (4 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; safety; R0002818:Table 2
A2	events	0 / 6	not stated; safety; R0002818:Table 2
A3	events	0 / 26	not stated; safety; R0002818:Results
A4	events	0 / 9	not stated; safety; R0002818:Table 2

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; safety; R0002818:Table 2
A2	events	0 / 6	not stated; safety; R0002818:Table 2
A3	events	1 / 16	not stated; safety; group:qw; R0002818:Table 2
A3	events	1 / 26	not stated; safety; R0002818:Results
A3	events	0 / 10	not stated; safety; group:q2w; R0002818:Table 2
A4	events	0 / 9	not stated; safety; R0002818:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; safety; R0002818:Table 2
A2	events	0 / 6	not stated; safety; R0002818:Table 2
A3	events	0 / 10	not stated; safety; group:q2w; R0002818:Table 2
A3	events	3 / 26	not stated; safety; R0002818:Figure 1
A3	events	3 / 16	not stated; safety; group:qw; R0002818:Table 2
A4	events	0 / 9	not stated; safety; R0002818:Table 2

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	5 / 18	not stated; safety; R0002818:Table 2
A2	events	2 / 6	not stated; safety; R0002818:Table 2
A3	events	2 / 10	not stated; safety; group:q2w; R0002818:Table 2
A3	events	9 / 16	not stated; safety; group:qw; R0002818:Table 2
A4	events	1 / 9	not stated; safety; R0002818:Table 2

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	5 / 18	not stated; safety; R0002818:Table 2
A2	events	0 / 6	not stated; safety; R0002818:Table 2
A3	events	1 / 10	not stated; safety; group:q2w; R0002818:Table 2
A3	events	4 / 16	not stated; safety; group:qw; R0002818:Table 2
A4	events	0 / 9	not stated; safety; R0002818:Table 2

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	5 / 18	not stated; safety; R0002818:Table 2
A2	events	1 / 6	not stated; safety; R0002818:Table 2
A3	events	4 / 10	not stated; safety; group:q2w; R0002818:Table 2
A3	events	7 / 16	not stated; safety; group:qw; R0002818:Table 2
A4	events	1 / 9	not stated; safety; R0002818:Table 2

Discontinuation due to gastrointestinal adverse events (6 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; safety; R0002818:Table 2
A2	events	0 / 6	not stated; safety; R0002818:Table 2
A3	events	3 / 16	not stated; safety; group:qw; R0002818:Results
A3	events	3 / 26	not stated; safety; R0002818:Results
A3	events	0 / 10	not stated; safety; group:q2w; R0002818:Table 2
A4	events	0 / 9	not stated; safety; R0002818:Table 2

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0002818:Results
	A3	events				0 / 26	not stated; safety; R0002818:Results

Death by suicide (4 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 18	not stated; safety; R0002818:Table 2
A2	events	0 / 6	not stated; safety; R0002818:Table 2
A3	events	0 / 26	not stated; safety; R0002818:Results
A4	events	0 / 9	not stated; safety; R0002818:Table 2