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Also known as ZGN-440 for injectable suspension, ZGN-440, ZGN-433
Beloranib · 4 trials · 1 indication
Safety and tolerability of beloranib will be assessed by comparing frequency and severity of adverse events as well as changes in physical examinations, ECGs, vital signs and laboratory evaluations. Other safety oriented questionnaires and parameters (e.g. sleep quality, hemodynamic parameters) will be measured and evaluated.
Change from baseline in body weight and body composition (bioimpedance assessments), and scores of hunger/appetite over the dosing period will be evaluated to document beloranib's effect on obesity. Biomarkers of lipid metabolism will be measured to assess possible mechanisms of loss of body fat, as well as endocrinologic or anti-inflammatory markers.
Measures of the safety and tolerability of ZGN-440 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | ZGN-440 sterile diluent |
| 0.3 mg Beloranib | EXPERIMENTAL | 0.3 mg ZGN-440 for injectable suspension |
| 0.6 mg Beloranib | EXPERIMENTAL | 0.6 mg ZGN-440 for injectable suspension |
| 1.2 mg Beloranib | EXPERIMENTAL | 1.2 mg ZGN-440 for injectable suspension |
| 2.4 mg Beloranib | EXPERIMENTAL | 2.4 mg ZGN-440 for injectable suspension |
| 3.2 mg Beloranib | EXPERIMENTAL | 3.2 mg ZGN-440 for injectable suspension |
| ZGN-440 sterile diluent | PLACEBO_COMPARATOR | - |
| ZGN-440 | EXPERIMENTAL | - |
| Normal Saline | PLACEBO_COMPARATOR | - |
| ZGN-433 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Beloranib | DRUG | Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated. |
| Placebo | DRUG | Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. |
| ZGN-440 | DRUG | Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated. |
| ZGN-440 sterile diluent | DRUG | Subjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated. |
| ZGN-433 | DRUG | Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated. |
| Normal Saline | DRUG | Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated. |
Inclusion Criteria: * Obese volunteers weighing ≥ 50 kg * BMI ≥ 30 and ≤ 50 kg/m2 * Stable body weight during the past 2 months * Type 2 diabetes mellitus is allowed Exclusion Criteria: * Use of weight loss agents in the past month * Current, clinically significant eating disorder * Type 1 diabet...
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Beloranib is an investigational small molecule developed by Larimar Therapeutics, Inc. (ticker LRMR) for the treatment of obesity. It is a metabolic therapy that has been studied in a Phase 2 clinical trial. Beloranib is not approved and remains in clinical development.
Beloranib is being developed for the treatment of obesity, a metabolic condition. Its clinical testing has focused on obese subjects. As an investigational agent, Beloranib has not been approved for any use and is still in clinical development.
Beloranib targets METAP2, also known as methionine aminopeptidase 2. It acts as an inhibitor of this enzyme. METAP2 inhibition is the mechanism through which Beloranib is designed to act in obesity.
Beloranib is being developed by Larimar Therapeutics, Inc., which trades under the ticker LRMR. The company is the sponsor of the drug's clinical program in obesity.
Beloranib is in Phase 2 development. It has completed one Phase 2 clinical trial in obesity. Beloranib is investigational and has not been approved by the FDA.
Beloranib has been studied in the Phase 2 trial NCT01666691, titled An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects. The trial was completed, enrolled 160 participants, was randomized, double-blind, and placebo-controlled, and was conducted in Australia.