An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus

Phase 2

Terminated

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Drug: ZGN-440 for Injectable Suspension; Drug: ZGN-440 Placebo for Injectable Suspension

• Registration Number: NCT02324491
• Lead Sponsor: Zafgen, Inc.

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 152

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZGN-440 Injectable Suspension (1.8mg)	ZGN-440 for Injectable Suspension	ZGN-440 for Injectable Suspension
Placebo	ZGN-440 Placebo for Injectable Suspension	ZGN-440 Placebo for Injectable Suspension
ZGN-440 Injectable Suspension (1.2mg)	ZGN-440 for Injectable Suspension	ZGN-440 for Injectable Suspension

Primary Outcome Measures

Name	Time	Method
Change in body weight	Baseline to Week 26
Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations	Baseline to Week 26 and Week 52

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Baseline to Week 52
Change in fasting glycemic parameters	Baseline to Week 26 and Week 52	HbA1c, plasma glucose
Change in cardiometabolic parameters	Baseline to Week 26 and Week 52	Blood pressure, lipid concentrations, hs-CRP
Change in Patient Reported Outcomes (PRO) scores	Baseline to Week 26 and Week 52

Trial Locations

Locations (16)

Ipswich Research Institute; 🇦🇺 Ipswich, Queensland, Australia

Austin Health; 🇦🇺 Heidelberg West, Victoria, Australia

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Illawara Diabetes Service; 🇦🇺 Wollongong, New South Wales, Australia

Australian Clinical Research Network; 🇦🇺 Maroubra, New South Wales, Australia

Pendlebury Research; 🇦🇺 Cardiff, New South Wales, Australia

Barwon Health; 🇦🇺 Geelong, Victoria, Australia

AusTrials; 🇦🇺 Sherwood, Queensland, Australia

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Baker IDI Heart and Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia

Emeritus Research; 🇦🇺 Malvern East, Victoria, Australia

Keogh Institute for Medical Research; 🇦🇺 Nedlands, Western Australia, Australia

Q-Pharm; 🇦🇺 Herston, Queensland, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

CMAX; 🇦🇺 Adelaide, South Australia, Australia

St. Vincent's Hospital; 🇦🇺 Fitzroy, Victoria, Australia