NCT00779519

Brief Summary

Multiple pathways including peripheral and central hormones and neurotransmitters are involved in the regulation of food intake and body weight. One of the most studied pathways involves the melanocortin receptor. Agouti-related protein (AgRP) and alpha-melanocyte stimulating hormone (alphaMSH)have been shown to play an integral role in food intake and body weight. It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in treating obesity.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 obesity

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

10 months

First QC Date

October 23, 2008

Last Update Submit

June 8, 2011

Conditions

Obesity

Keywords

ObesityClass 1Class 2Weight LossAgRPTTP435alphaMSHAgouti-Related Proteinalpha-melanocyte stimulating hormone

Outcome Measures

Primary Outcomes (1)

  • Participant Adverse Events

    Day 1 to Day 70 (2 weeks post dose)

Secondary Outcomes (8)

  • Change from Baseline Glucose Levels

    Day 1 to Day 70 (2 weeks post dose)

  • Absolute Change in Body Weight

    Day 1 to Day 70 (2 weeks post dose)

  • Absolute Change in Body Mass Index

    Day 1 to Day 70 (2 weeks post dose)

  • Percent Change in Body Weight After 8 Weeks of Treatment with TTP435 or Placebo

    Day 1 to Day 70 (2 weeks post dose)

  • Effect Subject-reported Satiety

    Day 1 to Day 70 (2 weeks post dose)

  • +3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

TTP435

EXPERIMENTAL
Drug: TTP435

Interventions

TTP435DRUG
TTP435
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female volunteers, aged 18 to 65 years, inclusive.
  • Subjects must be obese (class 1: BMI of 30.0 to 34.9 kg/m2 or class 2: BMI of 35 to 39.9 kg/m2 in non-Asians and BMI of 27.0 - 31.9 kg/m2 or 32.0 - 36.9 kg/m2 in Asians) at the Screening Visit.
  • Female subjects must be postmenopausal (with amenorrhea for at least 2 years prior to scheduled dosing and confirmatory FSH test in the range of 23-116 IU/L) or surgically sterile (with physician or insurance documentation of bilateral tubal ligation at least 6 months prior to Screening Visit or of a hysterectomy and/or bilateral oophorectomy) and agree not to undergo in vitro fertilization during the study and for 6 months post treatment.

You may not qualify if:

  • Type 1 diabetes.
  • Type 2 diabetes.
  • History of myocardial infarction, stroke, including transient ischemic attack, in the last 2 years.
  • Asthma or chronic obstructive pulmonary disease controlled by regular use of inhaled steroids.
  • Subjects with rheumatoid arthritis, lupus, or multiple sclerosis regularly requiring steroids or disease-modifying anti-rheumatic agents.
  • Subjects with psoriasis requiring oral steroids.
  • Subjects planning to undergo gastric bypass or resection surgery, or who have had such a procedure in the 6 months prior to the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

San Diego, California, 92130, United States

Location

Unknown Facility

Augusta, Georgia, 30909, United States

Location

Unknown Facility

Springfield, Illinois, 26704, United States

Location

Unknown Facility

Reno, Nevada, 89502, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Charlotte, North Carolina, 28277, United States

Location

Unknown Facility

Norfolk, Virginia, 23502, United States

Location

Unknown Facility

Richmond, Virginia, 23294, United States

Location

Unknown Facility

Halifax, Nova Scotia, B3K 5R3, Canada

Location

Unknown Facility

Oakville, Ontario, L6H 3P1, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • James Wamsley, MD

    vTv Therapeutics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 24, 2008

Study Start

February 1, 2009

Primary Completion

December 1, 2009

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

CA(3)US(9)