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ZGN-440 sterile diluent

Phase 2

Obesity | Small molecule | Oncology |Larimar Therapeutics, Inc.|Last Updated: Jul 18, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

ZGN-440 sterile diluent · 2 trials · 5 indications

Phase 2 2
NCT02063295An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic InjuryObesity
COMPLETED14 Analytics
NCT01818921An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi SyndromeObesity
COMPLETED17 Analytics
PHASE2COMPLETED
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
ObesityUnlock trial analytics
PHASE2COMPLETED
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in body weight from baseline to the end of the randomized dosing period.
4 weeks
Percent change in body weight from baseline to the end of the randomized dosing period.
4 weeks

Secondary Endpoints

Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period
4 weeks
Change in hs-CRP from baseline to the end of the randomized dosing period.
4 weeks
Change in hunger from baseline to the end of the randomized dosing period.
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZGN-440 sterile diluentPLACEBO_COMPARATORSubjects will receive placebo twice weekly subcutaneous injections for 4 weeks.
ZGN-440 for injectable suspensionEXPERIMENTALSubjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
1.2 mg ZGN-440 for injectable suspensionEXPERIMENTALSubjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.
1.8 mg ZGN-440 for injectable suspensionEXPERIMENTALSubjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Interventions

NameTypeDescription
ZGN-440 sterile diluentDRUGZGN-440 sterile diluent/placebo
ZGN-440 for injectable suspensionDRUG -
1.2 mg ZGN-440 for injectable suspensionDRUG1.2 mg beloranib
1.8 mg ZGN-440 for injectable suspensionDRUG1.8 mg beloranib
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2 * Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary * Stable body weight fo...

Countries:United StatesAustralia
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Frequently asked questions about ZGN-440 sterile diluent

What is ZGN-440 sterile diluent used for?

ZGN-440 sterile diluent is an investigational small molecule being developed by Larimar Therapeutics, Inc. (LRMR) for the treatment of obesity. It is currently in Phase 2 clinical development. The drug has been studied in patients with obesity and overweight conditions, including those with Prader-Willi Syndrome and hypothalamic injury.

Who makes ZGN-440 sterile diluent?

ZGN-440 sterile diluent 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 efficacy, safety, and pharmacokinetics in obese patients.

What phase is ZGN-440 sterile diluent in?

ZGN-440 sterile diluent is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, but the drug remains in clinical development and is not yet available for commercial use.

What clinical trials is ZGN-440 sterile diluent in?

ZGN-440 sterile diluent has been studied in two completed Phase 2 clinical trials. NCT01818921 evaluated the drug in obese subjects with Prader-Willi Syndrome, enrolling 17 participants in the United States. NCT02063295 assessed the drug in obese subjects with hypothalamic injury, enrolling 14 participants in the United States and Australia.

Is ZGN-440 sterile diluent the same as beloranib?

ZGN-440 sterile diluent is associated with the drug beloranib, as indicated by the clinical trial titles for NCT01818921 and NCT02063295, which both reference beloranib. The trials were conducted to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese patient populations.