Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMXB-A | Experimental | 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsules b.i.d. for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMXB-A | Drug | 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neuronal Response to Visual Food Cues | Neuronal response (insula) while viewing visual food cues | 14 weeks |
| Resting-state Neuronal Response | Neuronal response (default mode network) during rest | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight | 14 weeks |
| Fat Mass | Fat mass | 14 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason Tregellas, Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were recruited via flyer and email advertisement in Aurora, CO, between April 2016 and November 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo | Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neuronal Response to Visual Food Cues | Neuronal response (insula) while viewing visual food cues | Posted | Mean | Standard Deviation | % BOLD signal | 14 weeks |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristina Legget | University of Colorado School of Medicine | 3037245809 | kristian.legget@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2020 | Dec 21, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C088936 | 3-(2,4-dimethoxybenzylidene)anabaseine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo capsules b.i.d. for 12 weeks |
|
| Appetite Rating |
Hunger ratings via VAS scale (0-100) |
| 14 weeks |
Placebo capsules b.i.d. for 12 weeks.
Placebo: Placebo capsules b.i.d. for 12 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Resting-state Neuronal Response | Neuronal response (default mode network) during rest | Posted | Mean | Standard Deviation | Percent BOLD signal | 14 weeks |
|
|
|
|
| Secondary | Body Weight | Body weight | Not Posted | 14 weeks | Participants |
| Secondary | Fat Mass | Fat mass | Not Posted | 14 weeks | Participants |
| Secondary | Appetite Rating | Hunger ratings via VAS scale (0-100) | Not Posted | 14 weeks | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 16 |
| 30 |
| EG001 | Placebo | Placebo capsules b.i.d. for 12 weeks. Placebo: Placebo capsules b.i.d. for 12 weeks | 0 | 31 | 0 | 31 | 18 | 31 |
| Malaise | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Body aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Increased thirst | General disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Acid reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Bad breath | General disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Sore throat | General disorders | Systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Change in appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pink eye | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Forgetful | Nervous system disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.884 |
| Superiority |