Obesity
Conditions
Brief summary
Obesity is a serious and growing health problem in the United States. Obesity is associated with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased quality of life and increased mortality. Given the health and quality-of-life effects of obesity, developing effective treatments clearly is an important goal. This study plans to learn more about the effects of an investigational new drug (DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to affect appetite, the investigators are interested in studying effects of the study drug, which has some similarities to nicotine, on how your brain responds to such things as pictures of food. The study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental.
Interventions
DRUGDMXB-A
150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.
OTHERPlacebo
Placebo capsules b.i.d. for 12 weeks
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight/obese (BMI \> 27) * Between 21-65 years old
Exclusion criteria
* Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension * Women capable of conception (must be post-menopausal, surgically sterilized, or have adhered to an anti-contraception birth control regimen for at least 1 year) * Nicotine use * Significant endocrine/metabolic disease * Kidney disease * Neurological illness * Liver disease * Medication use affecting appetite and/or metabolism * MRI-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuronal Response to Visual Food Cues | 14 weeks | Neuronal response (insula) while viewing visual food cues |
| Resting-state Neuronal Response | 14 weeks | Neuronal response (default mode network) during rest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appetite Rating | 14 weeks | Hunger ratings via VAS scale (0-100) |
| Body Weight | 14 weeks | Body weight |
| Fat Mass | 14 weeks | Fat mass |
Countries
United States
Participant flow
Recruitment details
Participants were recruited via flyer and email advertisement in Aurora, CO, between April 2016 and November 2021.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Placebo Placebo capsules b.i.d. for 12 weeks.
Placebo: Placebo capsules b.i.d. for 12 weeks | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded for motion during MRI | 1 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | DMXB-A | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 44.17 years STANDARD_DEVIATION 11.27 | 43.93 years STANDARD_DEVIATION 11.07 | 43.71 years STANDARD_DEVIATION 11.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 52 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 48 Participants | 26 Participants |
| Region of Enrollment United States | 30 participants | 61 participants | 31 participants |
| Sex: Female, Male Female | 23 Participants | 45 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 16 / 30 | 18 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
Primary
Neuronal Response to Visual Food Cues
Neuronal response (insula) while viewing visual food cues
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DMXB-A | Neuronal Response to Visual Food Cues | Baseline | .035 % BOLD signal | Standard Deviation 0.073 |
| DMXB-A | Neuronal Response to Visual Food Cues | Post-intervention | .029 % BOLD signal | Standard Deviation 0.094 |
| Placebo | Neuronal Response to Visual Food Cues | Baseline | .045 % BOLD signal | Standard Deviation 0.095 |
| Placebo | Neuronal Response to Visual Food Cues | Post-intervention | .019 % BOLD signal | Standard Deviation 0.094 |
p-value: 0.647t-test, 2 sided
Comparison: DMXB-A vs. Placebo groups compared post-interventionp-value: 0.679t-test, 2 sided
Primary
Resting-state Neuronal Response
Neuronal response (default mode network) during rest
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DMXB-A | Resting-state Neuronal Response | Baseline | 2.008 Percent BOLD signal | Standard Deviation 0.072 |
| DMXB-A | Resting-state Neuronal Response | Post-intervention | 1.991 Percent BOLD signal | Standard Deviation 0.106 |
| Placebo | Resting-state Neuronal Response | Baseline | 2.009 Percent BOLD signal | Standard Deviation 0.064 |
| Placebo | Resting-state Neuronal Response | Post-intervention | 1.995 Percent BOLD signal | Standard Deviation 0.076 |
Comparison: DMXB-A vs. Placebo groups compared at baselinep-value: 0.951t-test, 2 sided
Comparison: DMXB-A vs. Placebo groups compared post-interventionp-value: 0.884t-test, 2 sided
Secondary
Appetite Rating
Hunger ratings via VAS scale (0-100)
Time frame: 14 weeks
Secondary
Body Weight
Body weight
Time frame: 14 weeks
Secondary
Fat Mass
Fat mass
Time frame: 14 weeks