MedDataX Logo

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

NCT ID: NCT01235741

Last Updated: 2015-04-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

NCT00673387

Overweight Obesity
COMPLETED PHASE2

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

NCT00392925

Overweight Obesity
COMPLETED PHASE2

A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

NCT00112021

Obesity
COMPLETED PHASE2

A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

NCT00189514

Obesity
COMPLETED PHASE2

A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

NCT00402077

Overweight Obesity
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Pramlintide+Metreleptin

Group Type EXPERIMENTAL

Pramlintide+Metreleptin

Intervention Type DRUG

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.

Group B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Senior Vice President, Research & Development

Role: STUDY_DIRECTOR

Amylin Pharmaceuticals, LLC.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Greenbrae, California, United States

Site Status

Research Site

La Jolla, California, United States

Site Status

Research Site

Denver, Colorado, United States

Site Status

Research Site

Winter Park, Florida, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Baton Rouge, Louisiana, United States

Site Status

Research Site

Hyattsville, Maryland, United States

Site Status

Research Site

Boston, Massachusetts, United States

Site Status

Research Site

St Louis, Missouri, United States

Site Status

Research Site

Butte, Montana, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Tulsa, Oklahoma, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Research Site

Salt Lake City, Utah, United States

Site Status

Research Site

Arlington, Virginia, United States

Site Status

Research Site

Norfolk, Virginia, United States

Site Status

Research Site

Richmond, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DFA104

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
NCT05164341 ACTIVE_NOT_RECRUITING PHASE3
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
NCT03041792 COMPLETED PHASE1
A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet
NCT05429593 COMPLETED PHASE1
Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
NCT00444561 COMPLETED PHASE2
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers
NCT02431442 COMPLETED PHASE1
A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)
NCT00092872 COMPLETED PHASE3
Anti-obesity Pharmacotherapy and Inflammation
NCT05756764 ACTIVE_NOT_RECRUITING
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
NCT04575194 UNKNOWN PHASE4
Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
NCT03287960 COMPLETED PHASE3
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
NCT03308721 COMPLETED PHASE1
Evaluation of the Effect of Pramlintide on Satiety and Food Intake
NCT00042601 COMPLETED PHASE2
Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
NCT01351753 TERMINATED PHASE2
Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)
NCT06854614 ACTIVE_NOT_RECRUITING PHASE4
Long-term Phentermine Pharmacotherapy: An Investigation for Symptoms of Dependence, Cravings, or Withdrawal
NCT01402674 COMPLETED NA
Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants
NCT01749137 COMPLETED PHASE2
Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity
NCT00709371 COMPLETED PHASE2
Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
NCT02870231 COMPLETED PHASE1
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
NCT03600480 COMPLETED PHASE1
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
NCT03661879 COMPLETED PHASE1
A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity
NCT05236517 COMPLETED PHASE1
A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety
NCT00375401 TERMINATED PHASE3
A Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess the Short-term Safety and Tolerability of Lorcaserin Plus Two Doses of Immediate-Release Phentermine-HCl Compared With Lorcaserin Alone in Overweight and Obese Adults
NCT01987427 COMPLETED PHASE4
Brown Adipose Tissue Activity in Response to Semaglutide Administered to Obese Subjects.
NCT05419726 RECRUITING
Setmelanotide in a Single Patient With Partial Lipodystrophy
NCT03262610 COMPLETED PHASE2
Study of Patients Being Treated With Anti-obesity Medication
NCT06790160 RECRUITING