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CompletedNCT00779519Updated Jun 27, 2011

Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss

A Phase 2 interventional study of TTP435 and Placebo in Obesity, sponsored by vTv Therapeutics. Completed at 12 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-27.

Sponsored by vTv Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Class 1
  • Class 2
  • Weight Loss
  • AgRP
  • TTP435
  • alphaMSH
  • Agouti-Related Protein
  • alpha-melanocyte stimulating hormone
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

vTv Therapeutics is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    TTP435

    Drug: TTP435

Interventions

  • DrugTTP435
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Participant Adverse Events

    Time frame: Day 1 to Day 70 (2 weeks post dose)

Secondary outcomes

  1. Change from Baseline Glucose Levels

    Time frame: Day 1 to Day 70 (2 weeks post dose)

  2. Absolute Change in Body Weight

    Time frame: Day 1 to Day 70 (2 weeks post dose)

  3. Absolute Change in Body Mass Index

    Time frame: Day 1 to Day 70 (2 weeks post dose)

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

    Time frame: Day 1 to Day 70 (2 weeks post dose)

  5. Effect Subject-reported Satiety

    Time frame: Day 1 to Day 70 (2 weeks post dose)

  6. Change from Baseline Insulin Levels

    Time frame: Day 1 to Day 70 (2 weeks post dose)

  7. Change from Baseline Free Fatty Acid Levels

    Time frame: Day 1 to Day 70 (2 weeks post dose)

  8. Change from Baseline Leptin Levels

    Time frame: Day 1 to Day 70 (2 weeks post dose)

07

Study locations

12 sites
  • Los Angeles, California 90095, United States
  • San Diego, California 92130, United States
  • Augusta, Georgia 30909, United States
  • Springfield, Illinois 26704, United States
  • Reno, Nevada 89502, United States
  • New York, New York 10065, United States
  • Charlotte, North Carolina 28277, United States
  • Norfolk, Virginia 23502, United States
  • Richmond, Virginia 23294, United States
  • Halifax, Nova Scotia B3K 5R3, Canada
  • Oakville, Ontario L6H 3P1, Canada
  • Toronto, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00779519
Lead sponsor
vTv Therapeutics
First posted
Oct 24, 2008
Start date
Feb 2009
Primary completion
Dec 2009
Last update
Jun 27, 2011

Study contacts

James Wamsley, MD
study chair · vTv Therapeutics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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