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Also known as Beloranib, Beloranib hemioxalate, ZGN-440 for injectable suspension, ZGN-440
ZGN-433 · 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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ZGN-433 is an investigational small molecule being developed for the treatment of obesity. It is a metabolic therapeutic that has been studied in Phase 1 clinical trials in obese female volunteers. The drug is not yet approved and remains in clinical development.
ZGN-433 is being developed by Larimar Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LRMR. The company has conducted Phase 1 clinical trials of ZGN-433 in Australia.
ZGN-433 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving obese female volunteers. The drug is investigational and has not been approved by regulatory authorities.
ZGN-433 has completed two Phase 1 clinical trials. The first, NCT01028261, studied multiple doses in 31 obese female volunteers. The second, NCT01372761, studied intravenous doses in 25 obese female volunteers. Both trials were conducted in Australia.