Trial Outcomes & Findings for Ghrelin Repeated Dose Study (NCT NCT01833078)

Results Overview

1.Safety: # of participants with treatment emergent adverse events

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

pre-treatment baseline through 30 days following the last administration of study treatment day 7

Results posted on

2015-10-08

Participant Flow

Participants were recruited from the outpatient medical practice serving the geriatric population at University of Pennsylvania via an electronic alert to physicians. Ten subjects were screened in order to obtain five eligible participants.

Participant milestones

Participant milestones
Measure	Ghrelin All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ghrelin Repeated Dose Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ghrelin n=5 Participants ghrelin: ghrelin administration subcutaneously for 7 days
Age, Continuous	86 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: pre-treatment baseline through 30 days following the last administration of study treatment day 7

1.Safety: # of participants with treatment emergent adverse events

Outcome measures

Outcome measures
Measure	Ghrelin n=5 Participants ghrelin: ghrelin administration subcutaneously for 7 days
Safety	4 participants

SECONDARY outcome

Timeframe: pre-treatment baseline (day 1) through day 7

Sustained food intake of standardized meal from Days 1 compared to Day 7.

Outcome measures

Outcome measures
Measure	Ghrelin n=5 Participants ghrelin: ghrelin administration subcutaneously for 7 days
Sustainability of Increased Caloric Intake Baseline (day 1)	691 calories Interval 587.0 to 1224.0
Sustainability of Increased Caloric Intake Day 7	839 calories Interval 548.0 to 1023.0

Adverse Events

Ghrelin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ghrelin n=5 participants at risk ghrelin: ghrelin administration subcutaneously for 7 days
General disorders tired	40.0% 2/5 • Study enrollment through one month following the final visit.
Gastrointestinal disorders mild diarrhea	20.0% 1/5 • Study enrollment through one month following the final visit.
Gastrointestinal disorders mild and transient abdominal discomfort, rumbling and flatulance	20.0% 1/5 • Study enrollment through one month following the final visit.
General disorders mild and transient headache	20.0% 1/5 • Study enrollment through one month following the final visit.
General disorders transient feeling of pronounced heartbeat	20.0% 1/5 • Study enrollment through one month following the final visit.
General disorders Mild fatigue	40.0% 2/5 • Study enrollment through one month following the final visit.
General disorders feeling of laziness	20.0% 1/5 • Study enrollment through one month following the final visit.

Additional Information

Dr. Anne Cappola, PI

University of Pennsylvania

Phone: 215-573-5359

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place