Current partner codePEPTIDESDE
NCT01235741·Phase 2·INTERVENTIONAL

A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects

Status

Terminated

Phase

Phase 2

Enrollment

213

Locations

18

Results

Posted

Publications

0

Study summary

What the protocol is testing.

Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.

Interventions

Treatment arms and agents.

DRUG

Pramlintide+Metreleptin

Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks.

DRUG

Placebo

Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.

Timeline

From registration to results.

  1. First posted

    Nov 8, 2010

  2. Study start

    Jan 2011

  3. Primary completion

    Sep 2011

  4. Study completion

    Sep 2011

  5. Results posted

    Dec 9, 2013

  6. Registry updated

    Apr 15, 2015

Outcomes

What the study measures.

Primary outcomes

Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population

Time frame · Day 1 up to Month 6 Follow-Up

Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.

Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population

Time frame · Baseline to Month 6 Follow Up

Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).

Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population

Time frame · Week 1 to Month 6 Follow-Up

Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.

Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin

Time frame · Baseline to Month 6 Follow-Up

In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.

Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population

Time frame · Screening to 6 Month Follow-Up

Criteria for laboratory values of potential clinical importance for obese and overweight (BMI \>= 25 kg/m\^2) participants: Platelets high (H) \>500,000/µL; low (L) \<75,000/µL. Hematocrit males \<36%, females \<30%. Hemoglobin males \<12 g/dL, females \<10 g/dL. White blood cell count (WBC) H \>18,000/µL; L \<1,500/µL. Urine protein H \>= 3+ or \>= 500 mg/dL. Urine glucose H \>= 3+ or \>= 500 mg/dL. Urine ketones \>= 3+ or Large.

Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population

Time frame · Screening to Month 6 Follow-Up

Criteria for laboratory values of potential clinical importance for obese and overweight (BMI \>= 25 kg/m\^2) participants: Total bilirubin High (H) \> 2 mg/dL; Plasma or serum glucose fasting or non-fasting H \> 200 mg/dL, low (L) \< 60 mg/dL; Albumin L \<2.5 g/dL; Creatine kinase H \> 3\*Upper limit of Normal (ULN); Sodium L \<130 milliequivalents per liter (mEq/L), H \> 150 mEq/L; potassium L\<3.0 mEq/L, H\> 5.5 mEq/L; bicarbonate L\<18 mEq/L, H\>35 mEq/L;calcium L \<8mg/dL, H\> 11 mg/dL; triglycerides H\> 500 mg/dL; Cholesterol L \< 100 mg/dL, H \> 350 mg/dL; Alkaline phosphatase H \> 3\*ULN; Gamma-glutamyltransferase H\>3\*ULN; creatinine males \> 1.6 mg/dL, females \> 1.4 mg/dL; alanine aminotransferase H \> 3\*ULN; aspartate aminotransferase H \> 3\*ULN; urea nitrogen H \> 45 mg/dL; uric acid males \> 10.0 mg/dL, females \> 8.0 mg/dL; Phosphorus L \< 1.0 mg/dL H \> 6.0 mg/dL.

Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population

Time frame · Baseline to Month 6 Follow-Up

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).

Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population

Time frame · Baseline up to Month 6 Follow-Up

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).

Secondary outcomes

Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population

Time frame · Baseline up to Month 6 Follow-Up

Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Is obese with a BMI ≥35 to ≤45 kg/m2. * Has stable body weight (not varying by \>5% within 3 months prior to study start). * Meets certain requirements with respect to concomitant medications. * Has not smoked or used nicotine-containing products for at least 12 months prior to study start. Exclusion Criteria: * Has not been enrolled in a weight loss program within 2 months prior to study start.

Study locations

18 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Research Site

Greenbrae, California, United States

Research Site

La Jolla, California, United States

Research Site

Denver, Colorado, United States

Research Site

Winter Park, Florida, United States

Research Site

Chicago, Illinois, United States

Research Site

Baton Rouge, Louisiana, United States

Research Site

Hyattsville, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

Butte, Montana, United States

Research Site

New York, New York, United States

Research Site

Tulsa, Oklahoma, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Austin, Texas, United States

Research Site

Salt Lake City, Utah, United States

Research Site

Arlington, Virginia, United States

Research Site

Norfolk, Virginia, United States

Research Site

Richmond, Virginia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.