Trial Outcomes & Findings for Three Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly (NCT NCT01410799)

NCT ID: NCT01410799

Last Updated: 2019-05-24

Results Overview

Pre-drug and post-drug 1 RM (Repetition Maximum) testing

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-05-24

Participant Flow

Participant milestones

Measure	Growth Hormone Releasing Hormone (GHRH) Drug: GHRH Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
Overall Study STARTED	13
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Growth Hormone Releasing Hormone (GHRH) Drug: GHRH Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
Overall Study PI decision	13

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Growth Hormone Releasing Hormone (GHRH) n=13 Participants Drug: GHRH Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
Age, Categorical <=18 years	0 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=13 Participants
Age, Categorical >=65 years	13 Participants n=13 Participants
Sex/Gender, Customized Male or Female	NA Participants n=13 Participants
Region of Enrollment United States	13 Participants n=13 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Study was terminated, no data collected.

Pre-drug and post-drug 1 RM (Repetition Maximum) testing

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Study was terminated, no data collected.

Glucose clamp study at week 12 of study drug use

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Study was terminated, no data collected.

iDXA scan

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Study was terminated, no data collected.

Assessment of resting metabolic rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Study was terminated, no data collected.

6 Minute Walk Test

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Ongoing throughout 12 weeks

Population: Study was terminated, no data collected.

Subjects record diary of drug administration in evening and morning describing any issues with pump system for drug delivery, local skin issues at site of injection or other adverse events. Study nurses also record telephone contact with subjects every other day for first week of dosing and weekly for first month.

Outcome measures

Outcome data not reported

Adverse Events

Growth Hormone Releasing Hormone (GHRH)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Growth Hormone Releasing Hormone (GHRH) n=13 participants at risk Drug: GHRH Growth Hormone Releasing Hormone (GHRH ): GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
Endocrine disorders Fatigue	7.7% 1/13 • Number of events 1

Additional Information

Dr. Anne Cappola

University of Pennsylvania

Phone: 215-573-5359

Email: acappola@upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place