Trial Outcomes & Findings for Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue (NCT NCT01783470)

Results Overview

difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

60 min after FDG administration

Results posted on

2019-06-11

Participant Flow

There were 15 participants who were enrolled. Three of them did not have cold-induced detectable brown fat, so they did not continue to the randomization. The remaining 12 participants had cold-induced brown fat, so they were randomized.

Participant milestones

Participant milestones
Measure	Placebo Then beta3-adrenergic Receptor (AR) Agonist Participants administered a lactose-based oral placebo followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received drug.	beta3-adrenergic Receptor (AR) Agonist Then Placebo Participants administered an oral beta3-AR agonist followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received placebo.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of b3-Adrenergic Receptor Agonists on Brown Adipose Tissue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants All participants randomized to placebo or drug first then received the other treatment second.
Age, Continuous	22.2 years STANDARD_DEVIATION 0.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 min after FDG administration

difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants lactose Placebo	beta3-adrenergic Receptor (AR) n=12 Participants
BAT Activity as Measured by 18F-FDG PET/CT	0.92 mLSUVmeang/mL Interval 0.48 to 2.82	132 mLSUVmeang/mL Interval 70.0 to 253.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 minutes before drug administration followed by 30 minutes after FDG administration

This is the energy expenditure as calculated using indirect calorimetry.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

beta3-adrenergic Receptor Agonist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild Cold Exposure

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

Aaron M. Cypess, MD, PhD, MMSc

NIDDK / NIH

Phone: 301-435-9267

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place