Clinical trial NCT02324491: An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Weight Reduction, Glycemic Control, Safety, and Tolerability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Type 2 Diabetes
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.

Detailed description: Phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.

Eligibility criteria: Inclusion Criteria:

* Obese with BMI ≥30 kg/m2
* Type 2 diabetes mellitus
* HbA1c of 7-11%
* Fasting glucose \<15.5 mmol/L
* Treated with diet and exercise alone or with a stable regimen of metformin, sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, SGLT-2 inhibitor or any combination of these agents
* Female subjects must be surgically sterile, post-menopausal or using long-acting contraception, which includes intrauterine devices or use of an implanted or injectable contraceptive

Exclusion Criteria:

* Current or recent use of insulin
* Severe hypoglycemia within the prior 6 months
* Metabolic disorders or genetic disorders linked to obesity (e.g., Prader-Willi Syndrome)

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to Week 26
measure: Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations
timeFrame: Baseline to Week 26 and Week 52
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline to Week 52
measure: Change in fasting glycemic parameters
timeFrame: Baseline to Week 26 and Week 52
measure: Change in cardiometabolic parameters
timeFrame: Baseline to Week 26 and Week 52
measure: Change in Patient Reported Outcomes (PRO) scores
timeFrame: Baseline to Week 26 and Week 52
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Cardiff
country: Australia
facility: Pendlebury Research
state: New South Wales
city: Maroubra
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Illawara Diabetes Service
state: New South Wales
city: Herston
country: Australia
facility: Q-Pharm
state: Queensland
city: Ipswich
country: Australia
facility: Ipswich Research Institute
state: Queensland
city: Sherwood
country: Australia
facility: AusTrials
state: Queensland
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Health
state: Victoria
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Melbourne
country: Australia
facility: Baker IDI Heart and Diabetes Institute
state: Victoria
city: Nedlands
country: Australia
facility: Keogh Institute for Medical Research
state: Western Australia
Study officials:
affiliation: Zafgen, Inc.
name: Dennis Kim, MD
role: STUDY_DIRECTOR
References:
citation: Proietto J, Malloy J, Zhuang D, Arya M, Cohen ND, de Looze FJ, Gilfillan C, Griffin P, Hall S, Nathow T, Oldfield GS, O'Neal DN, Roberts A, Stuckey BGA, Yue D, Taylor K, Kim D. Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial. Diabetologia. 2018 Sep;61(9):1918-1922. doi: 10.1007/s00125-018-4677-0. Epub 2018 Jul 11.