Obesity, Type 2 Diabetes
Conditions
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.
Interventions
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
Sponsors
Zafgen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Australia
Outcome results
None listed