Leptin in the Maintenance of Reduced Body Weight

NCT01155180 | Completed Phase 2 Results

• 2 other identifiers: 2008P000190R01DK079929
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

You are invited to take part in a research study about the role of leptin (a fat cell hormone that normally circulates in the blood) on maintaining a reduced body weight. This study will also evaluate how leptin impacts hormone levels, metabolic rate (how many calories are used at rest), autonomic nervous function (the part of your brain that controls your heart rate and breathing), changes in body composition and your sense of appetite. Under normal conditions, leptin is secreted by fat cells and signals to the brain to decrease appetite and regulate energy usage and hormone levels. When obese individuals lose weight, their leptin levels go down, which may cause them to later regain the weight. This study will provide leptin as an investigational medication (not yet approved by the Food and Drug Administration) to increase the levels of the leptin hormone that normally circulates in your blood back to a normal range. We will see if this can help you to maintain your reduced body weight and improve your hormonal and metabolic function.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Body Weight at 6 Months

  Body weight was recorded to the nearest 0.1 kg at baseline and at 6 months after randomization. Then the percentage change was calculated.

  baseline and 6 months after randomization

Study Arms (2)

Leptin

EXPERIMENTAL

We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Drug: Leptin

Placebo

PLACEBO COMPARATOR

We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women

Drug: Placebo

Interventions

Leptin DRUG

Hormone - daily self injections for 6 months

Also known as: metreleptin

Leptin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Body mass index (pre weight loss) between 30 and 40 kg/m2.
• Weight loss achieved over a period not greater than 6 months.

You may not qualify if:

• Use of a very low calorie diet in the year prior to the start of the study
• History of diabetes
• History of any illness that may affect the concentrations of the hormones to be studied (such as anemia, infectious diseases, renal or hepatic failure, cancer, lymphoma, clinically evident hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)
• On medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti seizure medications or thyroid hormones), or medications for weight loss.
• Known history of reactions or known hypersensitivity to E. Coli derived proteins
• Breast feeding, pregnant, or wanting to become pregnant during the next year
• Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.).
• Subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
• Subjects that exhibit noticeable anxiety and/or claustrophobia.
• Subjects who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function).
• Subjects who have significant sensory or motor impairment; - Subjects who suffer from epilepsy, in particular photo-sensitive epilepsy (this would be a risk for scanning with visual stimulation).
• Subjects with neurological problems that might interfere or complicate testing (e.g. presence of titubation).
• Subjects who cannot adhere to the experimental protocol for any reason.
• Age 18 or older.
• Body mass index (pre weight loss) between 30 and 40 kg/m2.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Leptin; metreleptin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adipokines; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Christos Manztoros
• Organization: Beth Israel Deaconess Medical Center

cmantzor@bidmc.harvard.edu

617-667-8630

Study Officials

• Christos S Mantzoros, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: July 1, 2010
• Study Start: July 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2016
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)