Approval Probability
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Adjusted LOA
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Beloranib · 1 trial · 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.
| 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 |
| 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. |
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 being developed for the treatment of obesity. It is a metabolic therapeutic that has been studied in a Phase 2 clinical trial. The drug is not approved and remains in clinical development.
Beloranib is being developed by Larimar Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol LRMR. The company is conducting clinical research to evaluate the drug's safety and efficacy in obese subjects.
Beloranib is in Phase 2 clinical development. It has completed a Phase 2 trial in obese subjects. The drug is investigational and has not been approved by regulatory authorities for any use.
Beloranib has been studied in one completed Phase 2 clinical trial, identified as NCT01666691. This randomized, double-blind, placebo-controlled study enrolled 160 obese subjects in Australia to evaluate the efficacy, safety, and pharmacokinetics of the drug.
Beloranib is also known as ZGN-440 for injectable suspension, as referenced in the clinical trial NCT01666691. This alternative name may be used in research publications and trial registries to refer to the same drug candidate.