MedDataX Logo

An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome

NCT ID: NCT01818921

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-11-30

Brief Summary

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

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.

Related Clinical Trials

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

Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome

NCT02179151

Prader-Willi Syndrome Obesity
TERMINATED PHASE3

An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects

NCT01666691

Obesity
COMPLETED PHASE2

An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

NCT02063295

Obesity Over-weight Hypothalamic Injury +1 more
COMPLETED PHASE2

ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity

NCT01507077

Obesity
COMPLETED PHASE1

Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

NCT01372761

Obesity
COMPLETED PHASE1

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 Over-weight Prader-Willi Syndrome

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

ZGN-440 sterile diluent

Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks.

Group Type PLACEBO_COMPARATOR

ZGN-440 sterile diluent

Intervention Type DRUG

ZGN-440 sterile diluent/placebo

1.2 mg ZGN-440 for injectable suspension

Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Group Type EXPERIMENTAL

1.2 mg ZGN-440 for injectable suspension

Intervention Type DRUG

1.2 mg beloranib

1.8 mg ZGN-440 for injectable suspension

Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Group Type EXPERIMENTAL

1.8 mg ZGN-440 for injectable suspension

Intervention Type DRUG

1.8 mg beloranib

Interventions

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

ZGN-440 sterile diluent

ZGN-440 sterile diluent/placebo

Intervention Type DRUG

1.2 mg ZGN-440 for injectable suspension

1.2 mg beloranib

Intervention Type DRUG

1.8 mg ZGN-440 for injectable suspension

1.8 mg beloranib

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo ZGN-440 for injectable suspension ZGN-440 ZGN-433 Beloranib ZGN-440 for injectable suspension ZGN-440 ZGN-433 Beloranib

Eligibility Criteria

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

Inclusion Criteria

* Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
* BMI ≥25 kg/m2
* Type 2 diabetes mellitus is allowed
* Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
* Stable body weight during the past 3 months, except for during home visits

Exclusion Criteria

* Use of weight loss agents in the past 3 months
* Type 1 diabetes mellitus
* Current or anticipated chronic use of narcotics or opiates
Minimum Eligible Age

16 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.

Zafgen, Inc.

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.

Jennifer Miller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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

University of Florida

Gainesville, Florida, 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.

ZAF-211

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
NCT02324491 TERMINATED PHASE2
Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome
NCT02311673 COMPLETED PHASE2
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
NCT06772597 RECRUITING PHASE2
A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity
NCT04010786 COMPLETED PHASE1
Aleniglipron Phase 2 Body Composition Study
NCT07169942 ACTIVE_NOT_RECRUITING PHASE2
Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects
NCT02235961 COMPLETED PHASE1
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight
NCT02958085 COMPLETED PHASE1
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese
NCT03600480 COMPLETED PHASE1
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
NCT03041792 COMPLETED PHASE1
A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
NCT01180465 COMPLETED PHASE2
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.
NCT02941042 COMPLETED PHASE1
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects
NCT00909766 COMPLETED PHASE1/PHASE2
A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906
NCT05751226 COMPLETED PHASE1
A Two Part Trial Investigating an Anti-obesity Drug in Overweight/Obese Male and Female Healthy Volunteers
NCT01044108 TERMINATED PHASE1
A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity
NCT07291232 RECRUITING PHASE1
Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
NCT03661879 COMPLETED PHASE1
A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants Receiving a Glucagon-like Peptide-1 (GLP-1) Agonist
NCT06500429 COMPLETED PHASE2
Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
NCT00785408 COMPLETED PHASE2
A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
NCT05369390 COMPLETED PHASE1
A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
NCT07081958 ACTIVE_NOT_RECRUITING PHASE2
A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety
NCT00375401 TERMINATED PHASE3
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
NCT02527200 COMPLETED PHASE3
A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years
NCT02696148 COMPLETED PHASE1
A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
NCT06259981 COMPLETED PHASE2
Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects
NCT02568319 COMPLETED PHASE2