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

A Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multiple Dose, Multicenter Study to Assess Safety and Tolerability of TTP435 in Obese (Class 1-2) Subjects Over 8 Weeks of Treatment

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00779519

Enrollment

100

Registered

2008-10-24

Start date

2009-02-28

Completion date

Unknown

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

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

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.

Interventions

DRUGTTP435

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame
Participant Adverse Events	Day 1 to Day 70 (2 weeks post dose)

Secondary

Measure	Time frame
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)
Change from Baseline Glucose Levels	Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Insulin Levels	Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Free Fatty Acid Levels	Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Leptin Levels	Day 1 to Day 70 (2 weeks post dose)
Effect Subject-reported Satiety	Day 1 to Day 70 (2 weeks post dose)

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026