Phase 1 Completed N=61 Randomized Double-blind Other

Nicotinic Agonist Effects on BMI and Neuronal Response

Obesity

Source: ClinicalTrials.gov NCT02458313 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcomePrimary: Neuronal Response to Visual Food Cues — .035; .045; .029; .019 % BOLD signal — p=0.647

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Neuronal Response to Visual Food Cues	.035; .045; .029; .019	0.647
PRIMARY Resting-state Neuronal Response	2.008; 2.009; 1.991; 1.995	0.951
SECONDARY Body Weight	—	—
SECONDARY Fat Mass	—	—
SECONDARY Appetite Rating	—	—

Eligibility Criteria

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 exclusion criteria (e.g., claustrophobia, metal in the body)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02458313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.