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Also known as Beloranib for subcutaneous injection, Beloranib, ZGN-440 for injectable suspension, ZGN-433
ZGN-440 · 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-440 is an investigational small molecule being developed for the treatment of obesity. It is administered by subcutaneous injection and is intended for use in metabolic conditions. The drug is currently in clinical development and has not been approved by regulatory authorities.
ZGN-440 is being developed by Larimar Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LRMR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating obesity.
ZGN-440 is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the drug in 25 participants with obesity. The drug remains investigational and is not yet approved for commercial use.
ZGN-440 has one completed Phase 1 clinical trial registered under NCT01507077, titled 'ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity.' The trial enrolled 25 female participants aged 18 years and older in Australia and was a randomized, double-blind, placebo-controlled study.
Yes, ZGN-440 is also known as beloranib. The clinical trial NCT01507077 refers to the drug as 'ZGN-440 (Beloranib for Subcutaneous Injection),' confirming that ZGN-440 and beloranib are the same investigational compound being studied for obesity.