Trial Outcomes & Findings for In Vivo Leptin Signaling in Humans After Acute Leptin Administration (NCT NCT01275053)

Results Overview

Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration. The primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration. The p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Baseline and 30 minutes

Results posted on

2017-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Leptin leptin: 0.01mg/kg
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In Vivo Leptin Signaling in Humans After Acute Leptin Administration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leptin n=12 Participants leptin: 0.01mg/kg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous All participants	43.3 years STANDARD_DEVIATION 10.78 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 30 minutes

Population: All subjects received biopsies before and 30 min after leptin administration.

Leptin signaling is assessed before and 30 minutes after in vivo metreleptin administration. The primary outcome was p-STAT3/STAT3 in biopsies (fat tissue) before and 30 minutes after in vivo metreleptin administration. The p-STAT3/STAT3 before metreleptin administration was given the value 1, and the p-STAT3/STAT3 30 minutes after in vivo metreleptin administration was given the value showing the fold change compared to p-STAT3/STAT3 before metreleptin administration.

Outcome measures

Outcome measures
Measure	Leptin n=12 Participants leptin: 0.01mg/kg
Leptin Signaling	3.1 fold change Interval 2.8 to 3.4

Adverse Events

Leptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christos Mantzoros

Beth Israel Deaconess Medical Center

Phone: 6176678633

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place