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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02324491
• Other study ID #: ZAF-203
• Status: Terminated
• Phase: Phase 2
• First received: December 18, 2014
• Last updated: January 4, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Zafgen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Drug:
• ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
• ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Pendlebury Research	Cardiff	New South Wales
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Austin Health	Heidelberg West	Victoria
Australia	Q-Pharm	Herston	Queensland
Australia	Ipswich Research Institute	Ipswich	Queensland
Australia	Emeritus Research	Malvern East	Victoria
Australia	Australian Clinical Research Network	Maroubra	New South Wales
Australia	Baker IDI Heart and Diabetes Institute	Melbourne	Victoria
Australia	Keogh Institute for Medical Research	Nedlands	Western Australia
Australia	AusTrials	Sherwood	Queensland
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Illawara Diabetes Service	Wollongong	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Zafgen, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Baseline to Week 26	No
Primary	Safety and tolerability assessed by adverse events, laboratory evaluations, ECGs, vital signs, physical examinations		Baseline to Week 26 and Week 52	Yes
Secondary	Change in body weight		Baseline to Week 52	No
Secondary	Change in fasting glycemic parameters	HbA1c, plasma glucose	Baseline to Week 26 and Week 52	No
Secondary	Change in cardiometabolic parameters	Blood pressure, lipid concentrations, hs-CRP	Baseline to Week 26 and Week 52	No
Secondary	Change in Patient Reported Outcomes (PRO) scores		Baseline to Week 26 and Week 52	No