Trial Outcomes & Findings for Nicotinic Agonist Effects on BMI and Neuronal Response (NCT NCT02458313)

NCT ID: NCT02458313

Last Updated: 2023-06-12

Results Overview

Neuronal response (insula) while viewing visual food cues

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

61 participants

Primary outcome timeframe

14 weeks

Results posted on

2023-06-12

Participant Flow

Participants were recruited via flyer and email advertisement in Aurora, CO, between April 2016 and November 2021.

Participant milestones

Participant milestones
Measure	DMXB-A 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. DMXB-A: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.	Placebo Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks
Overall Study STARTED	30	31
Overall Study COMPLETED	23	21
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Reasons for withdrawal
Measure	DMXB-A 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. DMXB-A: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.	Placebo Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks
Overall Study Withdrawal by Subject	6	8
Overall Study Excluded for motion during MRI	1	2

Baseline Characteristics

Nicotinic Agonist Effects on BMI and Neuronal Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DMXB-A n=30 Participants 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. DMXB-A: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.	Placebo n=31 Participants Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks	Total n=61 Participants Total of all reporting groups
Age, Continuous	44.17 years STANDARD_DEVIATION 11.27 • n=5 Participants	43.71 years STANDARD_DEVIATION 11.06 • n=7 Participants	43.93 years STANDARD_DEVIATION 11.07 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	31 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Neuronal response (insula) while viewing visual food cues

Outcome measures

Outcome measures
Measure	DMXB-A n=23 Participants 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. DMXB-A: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.	Placebo n=21 Participants Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks
Neuronal Response to Visual Food Cues Baseline	.035 % BOLD signal Standard Deviation .073	.045 % BOLD signal Standard Deviation .095
Neuronal Response to Visual Food Cues Post-intervention	.029 % BOLD signal Standard Deviation .094	.019 % BOLD signal Standard Deviation .094

PRIMARY outcome

Timeframe: 14 weeks

Neuronal response (default mode network) during rest

Outcome measures

Outcome measures
Measure	DMXB-A n=23 Participants 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. DMXB-A: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.	Placebo n=21 Participants Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks
Resting-state Neuronal Response Baseline	2.008 Percent BOLD signal Standard Deviation .072	2.009 Percent BOLD signal Standard Deviation .064
Resting-state Neuronal Response Post-intervention	1.991 Percent BOLD signal Standard Deviation .106	1.995 Percent BOLD signal Standard Deviation .076

SECONDARY outcome

Timeframe: 14 weeks

Body weight

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Fat mass

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 weeks

Hunger ratings via VAS scale (0-100)

Outcome measures

Outcome data not reported

Adverse Events

DMXB-A

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Kristina Legget

University of Colorado School of Medicine

Phone: 3037245809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DMXB-A n=30 participants at risk 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. DMXB-A: 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.	Placebo n=31 participants at risk Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks
General disorders Fever	6.7% 2/30 • Number of events 2 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Malaise	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Headache	10.0% 3/30 • Number of events 7 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	12.9% 4/31 • Number of events 5 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Musculoskeletal and connective tissue disorders Body aches	13.3% 4/30 • Number of events 4 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Dry mouth	3.3% 1/30 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	12.9% 4/31 • Number of events 6 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Increased thirst	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	6.5% 2/31 • Number of events 2 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Gastrointestinal disorders Flatulence	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Gastrointestinal disorders Acid reflux	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Insomnia	3.3% 1/30 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	9.7% 3/31 • Number of events 4 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Bad breath	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Gastrointestinal disorders Bloating	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Sore throat	10.0% 3/30 • Number of events 3 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Respiratory, thoracic and mediastinal disorders Congestion	10.0% 3/30 • Number of events 3 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	9.7% 3/31 • Number of events 3 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Drowsiness	3.3% 1/30 • Number of events 2 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Metabolism and nutrition disorders Change in appetite	3.3% 1/30 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	16.1% 5/31 • Number of events 7 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Gastrointestinal disorders Nausea	23.3% 7/30 • Number of events 9 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	6.5% 2/31 • Number of events 2 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Gastrointestinal disorders Diarrhea	13.3% 4/30 • Number of events 6 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	12.9% 4/31 • Number of events 6 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Gastrointestinal disorders Vomiting	3.3% 1/30 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	0.00% 0/31 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Eye disorders Pink eye	3.3% 1/30 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	0.00% 0/31 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Gastrointestinal disorders Constipation	3.3% 1/30 • Number of events 2 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Abdominal pain	3.3% 1/30 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Renal and urinary disorders Urinary tract infection	3.3% 1/30 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
Nervous system disorders Forgetful	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	6.5% 2/31 • Number of events 2 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.
General disorders Dizziness	0.00% 0/30 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.	3.2% 1/31 • Number of events 1 • Adverse event data collected at weeks 2, 4, 6, 8, and 10 of the intervention, and at the post-intervention visit, up to 14 weeks.