Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254368
• Other study ID #: ZAF-1061-201
• Secondary ID: U1111-1196-7527
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2017
• Est. completion date: February 22, 2019

Study information

• Verified date: May 2019
• Source: Zafgen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.

Description:

Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 22, 2019
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Subjects must meet the following criteria to participate in this study:

• Be between the ages of 18 and 70 years, inclusive.

• Overweight or obese with a body mass index of at least 27 kg/m².

• Have type 2 diabetes with HbA1c between 7% and 11%.

• For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.

• For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.

Exclusion Criteria:

Subjects cannot participate in this research study if they meet any of the following:

• Have taken another study drug or study device within the past 6 months.

• Are taking certain prescribed medications including narcotics or opiates.

• Consistent recent use of insulin.

• Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.

• Have a history of bleeding disorders or risk factors for excessive blood clotting.

• Have difficulty giving blood.

• Have a history of drug and/or alcohol abuse.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Overweight
• Overweight and Obesity
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ZGN-1061
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
• Placebo
Placebo has the same excipients and appearance as ZGN-1061

Locations

Country	Name	City	State
Australia	Eastern Clinical Research Unit (ECRU)	Box Hill	Victoria
Australia	Coffs Harbour GP SuperClinic	Coffs Harbour	New South Wales
Australia	Northside Health	Coffs Harbour	New South Wales
Australia	Southern Adelaide Diabetes & Endocrine Services	Daw Park	South Australia
Australia	Barwon Health	Geelong	Victoria
Australia	Q-Pharm	Herston	Queensland
Australia	The Aim Centre	Merewether	New South Wales
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Griffith University, Gold Coast Campus	Southport	Queensland
Australia	Holdsworth House Medical Practice	Sydney	New South Wales
Australia	Pendlebury Research	Sydney	New South Wales
Australia	The Boden Institute	Sydney	New South Wales
New Zealand	Middlemore Hospital	Auckland
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	Christchurch Diabetes Centre	Christchurch
New Zealand	Lipid and Diabetes Research Group	Christchurch
New Zealand	Southern Clinical Trials	Christchurch
New Zealand	Clinical Trials New Zealand Ltd	Hamilton
New Zealand	P3 Research Hawkes Bay	Hastings
New Zealand	P3 Research Wellington	Newtown
New Zealand	Lakeland Clinical Trials	Rotorua
New Zealand	P3 Research Tauranga	Tauranga
New Zealand	Wellington Hospital	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Zafgen, Inc.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		12 weeks
Primary	Safety and tolerability as assessed by incidence of adverse events		12 weeks
Primary	Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results		12 weeks
Secondary	Change in body weight		12 weeks
Secondary	Change in fasting plasma glucose		12 weeks
Secondary	Change in insulin		12 weeks
Secondary	Change in C-peptide		12 weeks
Secondary	Change in proinsulin		12 weeks
Secondary	Change in glucagon		12 weeks
Secondary	Proportion of subjects achieving HbA1c <7% and =6.5%		12 weeks
Secondary	Change in beta-cell function		12 weeks
Secondary	Change in insulin sensitivity		12 weeks
Secondary	Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects		12 weeks
Secondary	Change in waist and hip circumference		12 weeks
Secondary	Change in biomarkers relevant to obesity and/or type 2 diabetes		12 weeks
Secondary	Change in patient reported outcomes measures		12 weeks