ObesityPhase 2NCT00779519
Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss
A Phase 2 study testing TTP435 in people with Obesity, run by vTv Therapeutics at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- TTP435
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Feb 2009to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
Study site
Augusta, Georgia, 30909
Study site
Charlotte, North Carolina, 28277
Study site
Los Angeles, California, 90095
Study site
New York, New York, 10065
Study site
Norfolk, Virginia, 23502
Study site
Reno, Nevada, 89502
Study site
Richmond, Virginia, 23294
Study site
San Diego, California, 92130
Study site
Springfield, Illinois, 26704
Canada3 sites
Study site
Halifax, Nova Scotia, B3K 5R3
Study site
Oakville, Ontario, L6H 3P1
Study site
Toronto, Ontario
About this study
Official title: 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
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.
- Conditions
- Obesity
- Being tested
- TTP435, Placebo
- Keywords
- Obesity, Class 1, Class 2, Weight Loss, AgRP, TTP435, alphaMSH, Agouti-Related Protein, alpha-melanocyte stimulating hormone
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTP435Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| TTP435 | Experimental | Not described Receives: Drug: TTP435 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Adverse Events
Measured: Day 1 to Day 70 (2 weeks post dose)
Secondary outcomes (8)
Change from Baseline Glucose Levels
Measured: Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Weight
Measured: Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Mass Index
Measured: Day 1 to Day 70 (2 weeks post dose)
Percent Change in Body Weight After 8 Weeks of Treatment with TTP435 or Placebo
Measured: Day 1 to Day 70 (2 weeks post dose)
Effect Subject-reported Satiety
Measured: Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Insulin Levels
Measured: Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Free Fatty Acid Levels
Measured: Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Leptin Levels
Measured: Day 1 to Day 70 (2 weeks post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- vTv Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Wamsley, MD, Study chair, vTv Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779519
- Sponsor's protocol ID
- TTP435-201
- Status last verified
- Jun 2011
- First submitted
- 23 Oct 2008
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00779519
- Acronym / sponsor ID
- TTP435-201
- Conditions
- Obesity
- Keywords
- Obesity, Class 1, Class 2, Weight Loss, AgRP, TTP435, alphaMSH, Agouti-Related Protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- vTv TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- First posted
- 24 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| TTP435 | Experimental | Drug: TTP435 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTP435 | Drug | TTP435 |
| Placebo | Drug | Placebo |
Primary outcome
Participant Adverse Events
Time frame: Day 1 to Day 70 (2 weeks post dose)
8 secondary outcomes
Change from Baseline Glucose Levels
Time frame: Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Weight
Time frame: Day 1 to Day 70 (2 weeks post dose)
Absolute Change in Body Mass Index
Time frame: Day 1 to Day 70 (2 weeks post dose)
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)
Effect Subject-reported Satiety
Time frame: Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Insulin Levels
Time frame: Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Free Fatty Acid Levels
Time frame: Day 1 to Day 70 (2 weeks post dose)
Change from Baseline Leptin Levels
Time frame: Day 1 to Day 70 (2 weeks post dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Wamsley, MD study chair
vTv Therapeutics
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TTP435 in people with Obesity, run by vTv Therapeutics at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Adverse Events (time frame: Day 1 to Day 70 (2 weeks post dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.