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medical food with AN777, nutritional formula

Phase 3

Malnutrition | Unknown | Metabolic |Abbott Laboratories|Last Updated: Mar 7, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment331

FDA Designations

No designations recorded

Clinical trial landscape

medical food with AN777, nutritional formula · 1 trial · 2 indications

Phase 3 1
NCT01191125Evaluation of an Oral Nutritional Supplement Containing AN777Malnutrition
COMPLETED331 Analytics
PHASE3COMPLETED
Evaluation of an Oral Nutritional Supplement Containing AN777
MalnutritionUnlock trial analytics

Study Endpoints

Primary Endpoints

Knee extensor strength
Six months

Secondary Endpoints

Leg muscle mass
Six months
Body Weight
Six months
Functional measures
Six months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
medical food with AN777EXPERIMENTAL -
oral nutritional formulaACTIVE_COMPARATOR -

Interventions

NameTypeDescription
medical food with AN777OTHERTwo(220 mL)servings every day for six months
oral nutritional formulaOTHERTwo (220 mL) servings daily for six months
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Eligibility Criteria

Age Range65 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: Subject (male or female) is \> or equal to 65 and \< or equal to 90 years of age Subject is ambulatory Subject has a Subjective Global Assessment of B or C Subject has gait speed \<0.8 m/s AND/OR low hand-grip strength Subject has Class 1 or Class 2 sarcopenia Subject agree...

Countries:United StatesBelgiumItalyMexicoPolandSpainSwitzerlandUnited Kingdom
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Frequently asked questions about medical food with AN777, nutritional formula

What is AN777 used for?

AN777 is a medical food, a nutritional formula being studied for use in malnutrition. It is being evaluated in older adults, specifically for conditions including malnutrition and sarcopenia. The product is under development by Abbott Laboratories.

Who makes AN777?

Abbott Laboratories (NYSE: ABT) is the developer of AN777, a medical food nutritional formula. The company is conducting clinical research on this product for malnutrition and sarcopenia in older adults.

What phase is AN777 in?

AN777 is in Phase 3 clinical development. A Phase 3 trial has been completed, evaluating the oral nutritional supplement containing AN777 in 331 participants with malnutrition and sarcopenia.

What clinical trials is AN777 in?

AN777 has one completed Phase 3 clinical trial, NCT01191125, titled 'Evaluation of an Oral Nutritional Supplement Containing AN777'. The study enrolled 331 participants aged 65 years and older across multiple countries, including the United States, Belgium, Italy, Mexico, Poland, Spain, Switzerland, and the United Kingdom.

Is AN777 FDA approved?

AN777 is an investigational medical food and is still in clinical development. It is not approved by the FDA. A Phase 3 trial has been completed, but the product remains under investigation for malnutrition and sarcopenia.