Clinical trial NCT03254368: Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Overweight and Obesity
Keywords: Methionine Aminopeptidase 2 Inhibitor
Diabetes Mellitus, Type 2
Blood Glucose
Overweight
Obesity
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: 12 weeks
measure: Safety and tolerability as assessed by incidence of adverse events
timeFrame: 12 weeks
measure: Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in body weight
timeFrame: 12 weeks
measure: Change in fasting plasma glucose
timeFrame: 12 weeks
measure: Change in insulin
timeFrame: 12 weeks
measure: Change in C-peptide
timeFrame: 12 weeks
measure: Change in proinsulin
timeFrame: 12 weeks
measure: Change in glucagon
timeFrame: 12 weeks
measure: Proportion of subjects achieving HbA1c <7% and ≤6.5%
timeFrame: 12 weeks
measure: Change in beta-cell function
timeFrame: 12 weeks
measure: Change in insulin sensitivity
timeFrame: 12 weeks
measure: Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
timeFrame: 12 weeks
measure: Change in waist and hip circumference
timeFrame: 12 weeks
measure: Change in biomarkers relevant to obesity and/or type 2 diabetes
timeFrame: 12 weeks
measure: Change in patient reported outcomes measures
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Coffs Harbour
country: Australia
facility: Coffs Harbour GP SuperClinic
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Northside Health
state: New South Wales
city: Merewether
country: Australia
facility: The Aim Centre
state: New South Wales
city: Sydney
country: Australia
facility: The Boden Institute
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: Pendlebury Research
state: New South Wales
city: Herston
country: Australia
facility: Q-Pharm
state: Queensland
city: Southport
country: Australia
facility: Griffith University, Gold Coast Campus
state: Queensland
city: Daw Park
country: Australia
facility: Southern Adelaide Diabetes & Endocrine Services
state: South Australia
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit (ECRU)
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Diabetes Centre
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials
city: Christchurch
country: New Zealand
facility: Lipid and Diabetes Research Group
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand Ltd
city: Hastings
country: New Zealand
facility: P3 Research Hawkes Bay
city: Newtown
country: New Zealand
facility: P3 Research Wellington
city: Rotorua
country: New Zealand
facility: Lakeland Clinical Trials
city: Tauranga
country: New Zealand
facility: P3 Research Tauranga
city: Wellington
country: New Zealand
facility: Wellington Hospital
Study officials:
affiliation: Zafgen, Inc.
name: Dennis Kim, MD
role: STUDY_CHAIR
References: