parallel randomized trial

FALCON

A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of TERN-601 in Adults With Overweight or Obesity

Overweight or obesity without diabetes (adults)NCT06854952S002590

Design

Randomized: 167
Start year: 2025
Treatment: 12 weeks, follow-up 16 weeks
Countries: United States (17 sites)
Sponsor: Terns Pharmaceuticals (industry)
Eligibility: age 18 to 75; BMI 27 to below 50 with comorbidity if below 30; HbA1c below 6.5

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: not reported	33	26
A2	TERN-601 250 mg tablet once daily TERN-601 250 mg	lifestyle: not reported	33	27
A3	TERN-601 TERN-601 500 mg slow titration	lifestyle: not reported	34	28
A4	TERN-601 TERN-601 500 mg	lifestyle: not reported	34	28
A5	TERN-601 750 mg tablet once daily TERN-601 750 mg	lifestyle: not reported	33	28

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	TERN-601 250 mg tablet once daily A2	TERN-601 500 mg slow titration A3	TERN-601 500 mg A4	TERN-601 750 mg tablet once daily A5
age	mean (years)	51.2	47.6	48.1	53.6	50.5
age	sd (years)	12.9	15.9	13.3	11.4	13.8
asian	n	0	0	0	1	0
black	n	8	5	5	10	10
bmi	mean (kg/m2)	36.2	36.3	35.6	36.6	36.9
bmi	sd (kg/m2)	4.8	4.1	4.7	5.3	5.2
female	n	26	26	27	27	26
female	percent	78.8	78.8	79.4	79.4	78.8
hba1c	mean (percent)	5.5	5.6	5.5	5.5	5.5
hba1c	sd (percent)	0.4	0.4	0.3	0.4	0.4
hispanic	n	11	9	7	11	9
other race american indian alaska native	n	0	1	2	0	0
other race multiple	n	0	0	0	0	0
other race native hawaiian pacific islander	n	0	0	0	0	0
weight	mean (kg)	99.7	99.6	99.5	100.2	101.8
weight	sd (kg)	20.8	18.6	16.7	16.7	18.4
white	n	24	26	26	23	22
white	percent	72.7	78.8	76.5	67.6	66.7

Analyses this trial contributes to

Results

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

Percent body weight change (13 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	percent change	-0.30 percent	0.701		26	not stated; modified itt; registry:outcomes
12	A2	percent change	-2.11 percent	0.688		27	not stated; modified itt; registry:outcomes
12	A2 vs A1	md	-1.8 percent	0.9			not stated; modified itt; R0004304:Results
12	A2 vs A1	md	-1.81 percent		-3.4 to -0.3		not stated; modified itt; registry:outcomes
12	A3	percent change	-3.85 percent	0.687		28	not stated; modified itt; registry:outcomes
12	A3 vs A1	md	-3.6 percent	0.9			not stated; modified itt; R0004304:Results
12	A3 vs A1	md	-3.55 percent		-5.1 to -2.0		not stated; modified itt; registry:outcomes
12	A4	percent change	-4.87 percent	0.688		28	not stated; modified itt; registry:outcomes
12	A4 vs A1	md	-4.6 percent	0.9			not stated; modified itt; R0004304:Results
12	A4 vs A1	md	-4.58 percent		-6.1 to -3.0		not stated; modified itt; registry:outcomes
12	A5	percent change	-3.31 percent	0.688		28	not stated; modified itt; registry:outcomes
12	A5 vs A1	md	-3.0 percent	0.9			not stated; modified itt; R0004304:Results
12	A5 vs A1	md	-3.01 percent		-4.6 to -1.5		not stated; modified itt; registry:outcomes

Weight loss of 5 percent or more (9 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	responders			4 / 26	not stated; modified itt; registry:outcomes
12	A2	responders			4 / 27	not stated; modified itt; registry:outcomes
12	A2 vs A1	rd	-0.6	-17.9 to 16.5		not stated; modified itt; registry:outcomes
12	A3	responders			11 / 28	not stated; modified itt; registry:outcomes
12	A3 vs A1	rd	23.9	3.8 to 42.4		not stated; modified itt; registry:outcomes
12	A4	responders			13 / 28	not stated; modified itt; registry:outcomes
12	A4 vs A1	rd	31.0	10.4 to 49.3		not stated; modified itt; registry:outcomes
12	A5	responders			7 / 28	not stated; modified itt; registry:outcomes
12	A5 vs A1	rd	9.6	-9.0 to 27.7		not stated; modified itt; registry:outcomes

All cause mortality (5 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; safety; registry:adverse_events
A2	events	0 / 33	not stated; safety; registry:adverse_events
A3	events	0 / 34	not stated; safety; registry:adverse_events
A4	events	0 / 34	not stated; safety; registry:adverse_events
A5	events	0 / 33	not stated; safety; registry:adverse_events

Serious adverse events (5 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; safety; R0004304:Table 3
A2	events	0 / 33	not stated; safety; R0004304:Table 3
A3	events	0 / 34	not stated; safety; R0004304:Table 3
A4	events	1 / 34	not stated; safety; R0004304:Table 3
A5	events	2 / 33	not stated; safety; R0004304:Table 3

Discontinuation due to adverse events (10 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 33	not stated; safety; R0004304:Supplement Table S8
A1	events	1 / 33	not stated; randomized; registry:flow
A2	events	3 / 33	not stated; safety; R0004304:Supplement Table S8
A2	events	3 / 33	not stated; randomized; registry:flow
A3	events	4 / 34	not stated; safety; R0004304:Supplement Table S8
A3	events	0 / 34	not stated; randomized; registry:flow
A4	events	3 / 34	not stated; safety; R0004304:Supplement Table S8
A4	events	2 / 34	not stated; randomized; registry:flow
A5	events	6 / 33	not stated; safety; R0004304:Supplement Table S8
A5	events	2 / 33	not stated; randomized; registry:flow

Nausea (5 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	3 / 33	not stated; safety; R0004304:Table 2
A2	events	16 / 33	not stated; safety; R0004304:Table 2
A3	events	17 / 34	not stated; safety; R0004304:Table 2
A4	events	22 / 34	not stated; safety; R0004304:Table 2
A5	events	20 / 33	not stated; safety; R0004304:Table 2

Vomiting (5 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; safety; R0004304:Table 2
A2	events	2 / 33	not stated; safety; R0004304:Table 2
A3	events	10 / 34	not stated; safety; R0004304:Table 2
A4	events	13 / 34	not stated; safety; R0004304:Table 2
A5	events	11 / 33	not stated; safety; R0004304:Table 2

Diarrhea (5 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 33	not stated; safety; R0004304:Table 2
A2	events	4 / 33	not stated; safety; R0004304:Table 2
A3	events	4 / 34	not stated; safety; R0004304:Table 2
A4	events	4 / 34	not stated; safety; R0004304:Table 2
A5	events	1 / 33	not stated; safety; R0004304:Table 2

Constipation (5 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	1 / 33	not stated; safety; R0004304:Table 2
A2	events	2 / 33	not stated; safety; R0004304:Table 2
A3	events	2 / 34	not stated; safety; R0004304:Table 2
A4	events	8 / 34	not stated; safety; R0004304:Table 2
A5	events	4 / 33	not stated; safety; R0004304:Table 2

Discontinuation due to gastrointestinal adverse events (40 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; safety; abdominal pain upper; R0004304:Supplement Table S8
A1	events	0 / 33	not stated; safety; abdominal pain; R0004304:Supplement Table S8
A1	events	0 / 33	not stated; safety; constipation; R0004304:Supplement Table S8
A1	events	0 / 33	not stated; safety; diarrhea; R0004304:Supplement Table S8
A1	events	0 / 33	not stated; safety; dyspepsia; R0004304:Supplement Table S8
A1	events	0 / 33	not stated; safety; gastroesophageal reflux disease; R0004304:Supplement Table S8
A1	events	0 / 33	not stated; safety; nausea; R0004304:Supplement Table S8
A1	events	0 / 33	not stated; safety; vomiting; R0004304:Supplement Table S8
A2	events	0 / 33	not stated; safety; abdominal pain upper; R0004304:Supplement Table S8
A2	events	0 / 33	not stated; safety; abdominal pain; R0004304:Supplement Table S8
A2	events	0 / 33	not stated; safety; constipation; R0004304:Supplement Table S8
A2	events	0 / 33	not stated; safety; diarrhea; R0004304:Supplement Table S8
A2	events	1 / 33	not stated; safety; dyspepsia; R0004304:Supplement Table S8
A2	events	0 / 33	not stated; safety; gastroesophageal reflux disease; R0004304:Supplement Table S8
A2	events	2 / 33	not stated; safety; nausea; R0004304:Supplement Table S8
A2	events	0 / 33	not stated; safety; vomiting; R0004304:Supplement Table S8
A3	events	0 / 34	not stated; safety; abdominal pain upper; R0004304:Supplement Table S8
A3	events	0 / 34	not stated; safety; abdominal pain; R0004304:Supplement Table S8
A3	events	0 / 34	not stated; safety; constipation; R0004304:Supplement Table S8
A3	events	0 / 34	not stated; safety; diarrhea; R0004304:Supplement Table S8
A3	events	0 / 34	not stated; safety; dyspepsia; R0004304:Supplement Table S8
A3	events	0 / 34	not stated; safety; gastroesophageal reflux disease; R0004304:Supplement Table S8
A3	events	3 / 34	not stated; safety; nausea; R0004304:Supplement Table S8
A3	events	2 / 34	not stated; safety; vomiting; R0004304:Supplement Table S8
A4	events	1 / 34	not stated; safety; abdominal pain upper; R0004304:Supplement Table S8
A4	events	0 / 34	not stated; safety; abdominal pain; R0004304:Supplement Table S8
A4	events	1 / 34	not stated; safety; constipation; R0004304:Supplement Table S8
A4	events	1 / 34	not stated; safety; diarrhea; R0004304:Supplement Table S8
A4	events	0 / 34	not stated; safety; dyspepsia; R0004304:Supplement Table S8
A4	events	1 / 34	not stated; safety; gastroesophageal reflux disease; R0004304:Supplement Table S8
A4	events	1 / 34	not stated; safety; nausea; R0004304:Supplement Table S8
A4	events	1 / 34	not stated; safety; vomiting; R0004304:Supplement Table S8
A5	events	0 / 33	not stated; safety; abdominal pain upper; R0004304:Supplement Table S8
A5	events	1 / 33	not stated; safety; abdominal pain; R0004304:Supplement Table S8
A5	events	0 / 33	not stated; safety; constipation; R0004304:Supplement Table S8
A5	events	0 / 33	not stated; safety; diarrhea; R0004304:Supplement Table S8
A5	events	0 / 33	not stated; safety; dyspepsia; R0004304:Supplement Table S8
A5	events	0 / 33	not stated; safety; gastroesophageal reflux disease; R0004304:Supplement Table S8
A5	events	1 / 33	not stated; safety; nausea; R0004304:Supplement Table S8
A5	events	2 / 33	not stated; safety; vomiting; R0004304:Supplement Table S8

Gallbladder and biliary disease (5 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 33	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 34	not stated; safety; cholelithiasis; registry:adverse_events
A4	events	0 / 34	not stated; safety; cholelithiasis; registry:adverse_events
A5	events	1 / 33	not stated; safety; cholelithiasis; registry:adverse_events

Suicidal ideation or behavior (5 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; safety; suicidal ideation; registry:adverse_events
A2	events	1 / 33	not stated; safety; suicidal ideation; registry:adverse_events
A3	events	0 / 34	not stated; safety; suicidal ideation; registry:adverse_events
A4	events	0 / 34	not stated; safety; suicidal ideation; registry:adverse_events
A5	events	0 / 33	not stated; safety; suicidal ideation; registry:adverse_events