Nicotinic Agonist Effects on BMI and Neuronal Response

NCT02458313 | Completed Phase 1 Results DMC

• 2 other identifiers: 15-0650UL1TR001082
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Body Weight

  14 weeks

• Fat Mass

  14 weeks

• Appetite Rating

  14 weeks

Study Arms (2)

DMXB-A

EXPERIMENTAL

150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.

Drug: DMXB-A

Placebo

PLACEBO COMPARATOR

Placebo capsules b.i.d. for 12 weeks.

Other: Placebo

Interventions

DMXB-A DRUG

150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.

Also known as: 3-(2,4-dimethoxybenzylidene anabaseine

DMXB-A

Placebo OTHER

Placebo capsules b.i.d. for 12 weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight/obese (BMI \> 27)
• Between 21-65 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

3-(2,4-dimethoxybenzylidene)anabaseine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kristina Legget
• Organization: University of Colorado School of Medicine

kristian.legget@cuanschutz.edu

3037245809

Study Officials

• Jason Tregellas, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 1, 2015
• Study Start: April 14, 2016
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: June 12, 2023
• Results First Posted: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)