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

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

Official Title
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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

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Drug: ZGN-440 for Injectable Suspension
* Drug: ZGN-440 Placebo for Injectable Suspension


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZGN-440 Injectable Suspension (1.2mg)<br>ZGN-440 for Injectable Suspension | Drug: ZGN-440 for Injectable Suspension<br>* Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.<br>* Other names: ZGN-440;|
| Experimental: ZGN-440 Injectable Suspension (1.8mg)<br>ZGN-440 for Injectable Suspension | Drug: ZGN-440 for Injectable Suspension<br>* Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.<br>* Other names: ZGN-440;|
| Placebo Comparator: Placebo<br>ZGN-440 Placebo for Injectable Suspension | Drug: ZGN-440 Placebo for Injectable Suspension<br>* Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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