ObesityPhase 2NCT00050791
Effects of Leptin Treatment on Weight Loss
A Phase 2 study testing Leptin and Very Low Calorie Diet in people with Obesity, run by Rockefeller University at 1 site in United States.
Trial summary
This is a double blind placebo controlled clinical study designed to determine the effects of leptin on the changes that occur in the body during weight loss achieved by a very low calorie diet. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Leptin and Very Low Calorie Diet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Jun 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult females, age 25-45 with BMI 29-45, and no other acute or chronic illnesses. Pregnant women will not be permitted to participate in the study.
Who cannot join
- Chronic illnesses other the than mild forms illnesses related to obesity (hypertension, hyperlipidemia etc) that do not require medical treatment
- Diabetes Mellitus
- Chronic drug treatment for any medical conditions
- Inability to give informed consent
- Inability to give contact information (for outpatient follow up) including permanent residence, provide evidence of a stable living environment for the study period.
- Active weight reduction of more than 7 pounds in the last 3 months
Show all 16Show fewer
- Weight at screening more than 6% lower than the maximal life time weight.
- History of bleeding or blood clotting disorders.
- Changes in smoking habits for the last 3 months.
- Pregnancy or breast feeding in women.
- Allergic reaction to local anesthetics
- History of anaphylaxis or anaphylactoid-like reactions
- Tendency to form scars (keloids) easily
- Subjects with known hypersensitivity to E Coli-derived proteins or any other component of the A-100 preparation.
- Irregular menses
- HIV and hepatitis B or C positive subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10065
About this study
Official title: Leptin Treatment for Prevention of the Metabolic and Endocrine Sequelae of a Decreased Caloric Intake: Studies of Patients on a Very Low Calorie Diet
This is a double blind placebo controlled clinical study designed to determine the effects of leptin on the changes that occur in the body during weight loss achieved by a very low calorie diet.
Read the detailed description
Leptin is a hormone that is produced by the fat tissue and acts on the brain. Leptin plays a key role in regulating energy balance and body weight in animals and in humans.
When a person loses weight, leptin concentration in the blood is reduced. Reduction in blood leptin levels has been found to be related to a decreased metabolic rate (the rate in which the body burns its calories), an increased appetite, and to many other physiological and hormonal changes that may lead to failure in dieting.
This study is aimed to test if maintaining leptin in the pre-diet level range will ameliorate the changes that occur in the body during weight loss. If these changes are reduced, the process of weight loss could be easier and faster when adhering to a low calorie diet.
In this study, leptin or placebo is administered by an injection under the skin, in a way that is similar to injections of insulin to diabetic patients. 50% of the subjects participating in the study are treated by leptin and 50% are treated by placebo. Blood leptin levels are maintained in the pre-diet range in leptin treated subjects by leptin treatment. Subjects treated by placebo will also lose weight if they adhere to the liquid diet provided by the Rockefeller University Bio-nutrition Department. The investigators and the participants don't know if leptin or placebo are used since this is a double blind study.
To participate in this study, subjects have to stay at the Rockefeller University Hospital as inpatients for about two months and continue the study as outpatients for 4 more months. During the outpatient period, subjects have to attend a clinic visit once a week. During the first 3 weeks of the study, subjects are introduced to a weight stabilization liquid diet. During this time, the initial weight is maintained and baseline study tests are performed. When testing is completed, a very low calorie liquid diet and leptin or placebo administration are initiated. Weight is monitored until 10% weight loss is achieved. At this time, a second testing period is performed in an inpatient setting. When testing is completed, weight loss and leptin or placebo treatment continue at home in an outpatient setting until 20% weight loss is achieved. When this period is completed, a third testing period is performed in an inpatient setting. The last month of the study is dedicated to a transition from the liquid diet to solid food, and to weight maintenance education provided by the hospital staff in an outpatient setting. A solid food weight maintenance diet is provided to participants during this period. At the end of this period, two days of testing are performed and leptin/placebo administration is discontinued.
Study testing periods are performed over 12 days in an inpatient setting and include a variety of blood draws, urine collection, and metabolic and behavioral tests that are known to be affected by weight loss.
- Conditions
- Obesity
- Being tested
- Leptin, Very Low Calorie Diet
- Keywords
- Obesity, Weightloss, Leptin, Diet, Reducing, Overweight, Fat
- Medical subject headings
- Obesity, Weight Loss, Overweight, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeptinDrug
Also called A-100, Recombinant-methionyl Human Leptin (r-metHuLeptin)
Leptin is an adipocyte hormone that functions as an afferent signal in a feedback loop regulating body weight
Very Low Calorie DietBehavioural
placebo injections
| Study group | Role | What they receive |
|---|---|---|
| VLCD and leptin | Experimental | Very low calorie diet formula providing 800 calories per day and leptin treatment. Receives: Drug: Leptin |
| placebo | Active comparator | Very low calorie diet and placebo treatment Receives: Behavioral: Very Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy expenditure after 10% and 20% weight loss, achieved by a VLCD with or without A-100 treatment
Measured: Testing period 2,3 and 4 after 10% and 20% weight loss
Secondary outcomes (1)
endocrine and behavioral parameters
Measured: testing period 2, 3 and 4. After 10% and 20% weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2002 (estimated)
- Study startMar 2001
- Primary completionNov 2006
- Study completionJun 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, St. Luke's-Roosevelt Hospital Center, Columbia University
- Investigators
- Jeffrey Friedman, MD, PHD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050791
- Sponsor's protocol ID
- JFN 0357
- Status last verified
- Oct 2010
- First submitted
- 19 Dec 2002
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptin Treatment for Prevention of the Metabolic and Endocrine Sequelae of a Decreased Caloric Intake: Studies of Patients on a Very Low Calorie Diet
- ClinicalTrials.gov ID
- NCT00050791
- Acronym / sponsor ID
- JFN 0357
- Conditions
- Obesity
- Keywords
- Obesity, Weightloss, Leptin, Diet, Reducing, Overweight, Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, St. Luke's-Roosevelt Hospital Center, Columbia University
- Study start
- Mar 2001
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Dec 2002 (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.
This is a double blind placebo controlled clinical study designed to determine the effects of leptin on the changes that occur in the body during weight loss achieved by a very low calorie diet.
Detailed description
Leptin is a hormone that is produced by the fat tissue and acts on the brain. Leptin plays a key role in regulating energy balance and body weight in animals and in humans.
When a person loses weight, leptin concentration in the blood is reduced. Reduction in blood leptin levels has been found to be related to a decreased metabolic rate (the rate in which the body burns its calories), an increased appetite, and to many other physiological and hormonal changes that may lead to failure in dieting.
This study is aimed to test if maintaining leptin in the pre-diet level range will ameliorate the changes that occur in the body during weight loss. If these changes are reduced, the process of weight loss could be easier and faster when adhering to a low calorie diet.
In this study, leptin or placebo is administered by an injection under the skin, in a way that is similar to injections of insulin to diabetic patients. 50% of the subjects participating in the study are treated by leptin and 50% are treated by placebo. Blood leptin levels are maintained in the pre-diet range in leptin treated subjects by leptin treatment. Subjects treated by placebo will also lose weight if they adhere to the liquid diet provided by the Rockefeller University Bio-nutrition Department. The investigators and the participants don't know if leptin or placebo are used since this is a double blind study.
To participate in this study, subjects have to stay at the Rockefeller University Hospital as inpatients for about two months and continue the study as outpatients for 4 more months. During the outpatient period, subjects have to attend a clinic visit once a week. During the first 3 weeks of the study, subjects are introduced to a weight stabilization liquid diet. During this time, the initial weight is maintained and baseline study tests are performed. When testing is completed, a very low calorie liquid diet and leptin or placebo administration are initiated. Weight is monitored until 10% weight loss is achieved. At this time, a second testing period is performed in an inpatient setting. When testing is completed, weight loss and leptin or placebo treatment continue at home in an outpatient setting until 20% weight loss is achieved. When this period is completed, a third testing period is performed in an inpatient setting. The last month of the study is dedicated to a transition from the liquid diet to solid food, and to weight maintenance education provided by the hospital staff in an outpatient setting. A solid food weight maintenance diet is provided to participants during this period. At the end of this period, two days of testing are performed and leptin/placebo administration is discontinued.
Study testing periods are performed over 12 days in an inpatient setting and include a variety of blood draws, urine collection, and metabolic and behavioral tests that are known to be affected by weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLCD and leptin | Experimental | Drug: LeptinVery low calorie diet formula providing 800 calories per day and leptin treatment. |
| placebo | Active comparator | Behavioral: Very Low Calorie DietVery low calorie diet and placebo treatment |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult females, age 25-45 with BMI 29-45, and no other acute or chronic illnesses. Pregnant women will not be permitted to participate in the study.
Key exclusion criteria (16 listed)
- Chronic illnesses other the than mild forms illnesses related to obesity (hypertension, hyperlipidemia etc) that do not require medical treatment
- Diabetes Mellitus
- Chronic drug treatment for any medical conditions
- Inability to give informed consent
- Inability to give contact information (for outpatient follow up) including permanent residence, provide evidence of a stable living environment for the study period.
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 |
|---|---|---|
| LeptinAlso: A-100, Recombinant-methionyl Human Leptin (r-metHuLeptin)Leptin is an adipocyte hormone that functions as an afferent signal in a feedback loop regulating body weight | Drug | VLCD and leptin |
| Very Low Calorie Dietplacebo injections | Behavioural | placebo |
Primary outcome
energy expenditure after 10% and 20% weight loss, achieved by a VLCD with or without A-100 treatment
Time frame: Testing period 2,3 and 4 after 10% and 20% weight loss
1 secondary outcome
endocrine and behavioral parameters
Time frame: testing period 2, 3 and 4. After 10% and 20% weight loss
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 19 Oct 2010.
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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.
Jeffrey Friedman, MD, PHD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leptin and Very Low Calorie Diet in people with Obesity, run by Rockefeller University at 1 site in United States.
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 1 inclusion and 16 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 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
energy expenditure after 10% and 20% weight loss, achieved by a VLCD with or without A-100 treatment (time frame: Testing period 2,3 and 4 after 10% and 20% weight loss). 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 19 Oct 2010; AzTrials last refreshed its copy on 7 Nov 2026.