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

Zafgen

Status and phase: Terminated; Phase 2

Conditions: Obesity; Type 2 Diabetes

Treatments: Drug: ZGN-440 Placebo for Injectable Suspension; Drug: ZGN-440 for Injectable Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT02324491

ZAF-203

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.

Full description

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

Enrollment: 152 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 3 patient groups, including a placebo group

ZGN-440 Injectable Suspension (1.2mg)

Experimental group

Description:

ZGN-440 for Injectable Suspension

Treatment:

Drug: ZGN-440 for Injectable Suspension

ZGN-440 Injectable Suspension (1.8mg)

Experimental group

Description:

ZGN-440 for Injectable Suspension

Treatment:

Drug: ZGN-440 for Injectable Suspension

Placebo

Placebo Comparator group

Description:

ZGN-440 Placebo for Injectable Suspension

Treatment:

Drug: ZGN-440 Placebo for Injectable Suspension