ObesityPhase 1NCT02458313
Nicotinic Agonist Effects on BMI and Neuronal Response
A Phase 1 study testing DMXB-A in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- DMXB-A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2016to 13 Dec 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese (BMI > 27)
- Between 21-65 years old
Who cannot join
- 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
Show all 9Show fewer
- Liver disease
- Medication use affecting appetite and/or metabolism
- MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults
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.
- Conditions
- Obesity
- Being tested
- DMXB-A, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMXB-ADrug
Also called 3-(2,4-dimethoxybenzylidene anabaseine
150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.
PlaceboOther
Placebo capsules b.i.d. for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| DMXB-A | Experimental | 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. Receives: Drug: DMXB-A |
| Placebo | Placebo comparator | Placebo capsules b.i.d. for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuronal Response to Visual Food Cues
Neuronal response (insula) while viewing visual food cues
Measured: 14 weeks
Resting-state Neuronal Response
Neuronal response (default mode network) during rest
Measured: 14 weeks
Secondary outcomes (3)
Body Weight
Body weight
Measured: 14 weeks
Fat Mass
Fat mass
Measured: 14 weeks
Appetite Rating
Hunger ratings via VAS scale (0-100)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start14 Apr 2016
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Tregellas, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458313
- Sponsor's protocol ID
- 15-0650
- Other IDs
- UL1TR001082
- Status last verified
- May 2023
- First submitted
- 21 May 2015
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults
- ClinicalTrials.gov ID
- NCT02458313
- Acronym / sponsor ID
- 15-0650
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMXB-A | Experimental | Drug: DMXB-A150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo capsules b.i.d. for 12 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight/obese (BMI > 27)
- Between 21-65 years old
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMXB-AAlso: 3-(2,4-dimethoxybenzylidene anabaseine150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks. | Drug | DMXB-A |
| PlaceboPlacebo capsules b.i.d. for 12 weeks | Other | Placebo |
Primary outcome
Neuronal Response to Visual Food Cues
Time frame: 14 weeks
Neuronal response (insula) while viewing visual food cues
Resting-state Neuronal Response
Time frame: 14 weeks
Neuronal response (default mode network) during rest
3 secondary outcomes
Body Weight
Time frame: 14 weeks
Fat Mass
Time frame: 14 weeks
Appetite Rating
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Tregellas, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DMXB-A in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuronal Response to Visual Food Cues (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.