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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05378893
Registration number
NCT05378893
Ethics application status
Date submitted
25/03/2022
Date registered
18/05/2022
Date last updated
18/11/2023
Titles & IDs
Public title
A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624
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Scientific title
A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-and-Multiple-Ascending Subcutaneous Doses of DR10624
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Secondary ID [1]
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DR10624-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy, Obesity, Metabolically
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DR10624 for injection
Treatment: Drugs - Placebo
Experimental: Single-ascending dose:Part1:DR10624 - Escalating doses of DR10624 for injection administered subcutaneously in healthy participants or obese but otherwise healthy participants
Placebo Comparator: Single-ascending dose:Part1:placebo - Escalating doses of placebo for injection administered subcutaneously in in healthy participants or obese but otherwise healthy participants
Experimental: Multiple-ascending dose:Part2:DR10624 - Escalating doses of DR10624 for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia
Placebo Comparator: Multiple-ascending dose:Part2:placebo - Escalating doses of placebo for injection administered subcutaneously in obese adult subjects with moderate hypertriglyceridemia
Treatment: Drugs: DR10624 for injection
administered via subcutaneous injection
Treatment: Drugs: Placebo
administered via subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with one or more treatment-emergent adverse event (TEAE), serious adverse event (SAE) and adverse event of special interest (AESI).
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Assessment method [1]
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Number of participants with one or more TEAE, SAE and AESI.
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Timepoint [1]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [1]
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Area under the serum concentration versus time curve (AUC)
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Assessment method [1]
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Area under the serum concentration versus time curve (AUC)
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Timepoint [1]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [2]
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Maximum observed serum concentration (Cmax)
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Assessment method [2]
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Maximum observed serum concentration (Cmax)
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Timepoint [2]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [3]
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Time to reach maximum observed serum concentration (Tmax)
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Assessment method [3]
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Time to reach maximum observed serum concentration (Tmax)
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Timepoint [3]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [4]
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Terminal elimination half-life (t1/2)
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Assessment method [4]
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Terminal elimination half-life (t1/2)
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Timepoint [4]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [5]
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Mean residence time (MRT)
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Assessment method [5]
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Mean residence time (MRT)
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Timepoint [5]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [6]
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Apparent clearance after extravascular administration (CL/F)
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Assessment method [6]
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Apparent clearance after extravascular administration (CL/F)
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Timepoint [6]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [7]
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Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vz/F)
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Assessment method [7]
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Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vz/F)
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Timepoint [7]
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baseline through day 29(part 1)or day 106(part 2)
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Secondary outcome [8]
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AUC from time 0 to the time of the dosing interval (AUC0-t)
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Assessment method [8]
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AUC from time 0 to the time of the dosing interval (AUC0-t)
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Timepoint [8]
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baseline through day 106(part 2)
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Secondary outcome [9]
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Accumulation ratio (AR)
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Assessment method [9]
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Accumulation ratio (AR)
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Timepoint [9]
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baseline through day 106(part 2)
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Secondary outcome [10]
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Predose concentrations(Ctrough)
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Assessment method [10]
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Predose concentrations(Ctrough)
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Timepoint [10]
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baseline through day 106(part 2)
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Secondary outcome [11]
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change in body weight
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Assessment method [11]
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change in body weight
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Timepoint [11]
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baseline through Day 85
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Secondary outcome [12]
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change in adiponectin
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Assessment method [12]
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change in adiponectin
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Timepoint [12]
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baseline through Day 85
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Secondary outcome [13]
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change in BMI
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Assessment method [13]
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change in BMI
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Timepoint [13]
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baseline through Day 85
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Secondary outcome [14]
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change in waist circumference
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Assessment method [14]
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change in waist circumference
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Timepoint [14]
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baseline through Day 85
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Secondary outcome [15]
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change in fasting lipid profile
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Assessment method [15]
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change in fasting lipid profile
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Timepoint [15]
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baseline through Day 85
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Secondary outcome [16]
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change in fasting plasma glucose (FPG)
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Assessment method [16]
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change in FPG
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Timepoint [16]
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baseline through Day 85
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Secondary outcome [17]
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change in HbA1c
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Assessment method [17]
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change in HbA1c
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Timepoint [17]
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baseline through Day 85
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Secondary outcome [18]
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change in C-peptide
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Assessment method [18]
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change in C-peptide
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Timepoint [18]
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baseline through Day 85
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Secondary outcome [19]
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change in fasting insulin
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Assessment method [19]
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change in fasting insulin
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Timepoint [19]
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baseline through Day 85
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Secondary outcome [20]
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change in glucagon
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Assessment method [20]
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change in glucagon
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Timepoint [20]
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baseline through Day 85
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Secondary outcome [21]
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change in homeostatic model assessment index of insulin resistance (HOMA-IR) and homeostatic model assessment index of beta-cell function (HOMA-B)
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Assessment method [21]
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change in HOMA-IR and HOMA-B
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Timepoint [21]
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baseline through Day 85
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Secondary outcome [22]
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change in Partial area glucose level versus time curve from time 0 to 4 hours (?AUC0-4h)
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Assessment method [22]
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change in Partial area glucose levels versus time curve from time 0 to 4 hours (?AUC0-4h)
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Timepoint [22]
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baseline through Day 85
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Secondary outcome [23]
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change in Partial area insulin level versus time curve from time 0 to 4 hours (?AUC0-4h)
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Assessment method [23]
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change in Partial area insulin levels versus time curve from time 0 to 4 hours (?AUC0-4h)
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Timepoint [23]
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baseline through Day 85
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Secondary outcome [24]
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change in Partial area C-peptide level versus time curve from time 0 to 4 hours (?AUC0-4h)
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Assessment method [24]
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change in Partial area C-peptide levels versus time curve from time 0 to 4 hours (?AUC0-4h)
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Timepoint [24]
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baseline through Day 85
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Secondary outcome [25]
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change in Partial area glucagon level versus time curve from time 0 to 4 hours (?AUC0-4h)
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Assessment method [25]
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change in Partial area glucagon levels versus time curve from time 0 to 4 hours (?AUC0-4h)
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Timepoint [25]
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baseline through Day 85
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Secondary outcome [26]
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change percentage of time spent of glucose in target range 3.9 to 10 mmol/L (TIR), time above target range (TAR), time below target range (TBR), 24-hour mean glucose, and glucose variability
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Assessment method [26]
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change in TIR, TAR, TBR, 24-hour mean glucose, and glucose variability
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Timepoint [26]
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baseline through Day 85
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Secondary outcome [27]
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change in hepatic fat fraction measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF ) in part 2
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Assessment method [27]
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change in hepatic fat fraction measured by MRI-PDFF in part 2
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Timepoint [27]
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baseline through Day 85
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Secondary outcome [28]
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Change in liver stiffness by FibroScan in subjects with baseline hepatic fat of at least 8%
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Assessment method [28]
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Change in liver stiffness by FibroScan in subjects with baseline hepatic fat of at least 8%
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Timepoint [28]
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baseline through Day 85
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Secondary outcome [29]
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Change in the liver function parameters (ALT, AST, alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT))
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Assessment method [29]
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Change in the liver function (ALT, AST, alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT))
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Timepoint [29]
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baseline through Day 85
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Secondary outcome [30]
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Change in Fibrosis 4 score (FIB-4) and non-alcoholic fatty liver disease fibrosis score (NFS)
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Assessment method [30]
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Change in FIB-4 and NFS
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Timepoint [30]
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baseline through Day 85
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Eligibility
Key inclusion criteria
1. The subject is considered by the investigator to be in good general health as
determined by medical history, clinical laboratory test results, vital sign
measurements, 12-lead ECG results, and physical examination findings at screening.
2. Female subjects (heterosexually active, of childbearing potential, not pregnant, not
trying to become pregnant, and not lactating) are eligible to participate if they
agree to total abstinence from heterosexual intercourse or use a highly effective
method of birth control listed below, from screening through until at least 30 days
after the last dose of the study drug.
Male subjects with female partners of childbearing potential are eligible to
participate if they are vasectomized, or agree to total abstinence from heterosexual
intercourse, from screening through until at least 30 days after the last study dose,
or use of an effective method of birth control listed above, from screening through
until at least 30 days after the last study dose. Male subjects must refrain from
sperm donation throughout the study and for 30 days after the last study dose.
3. The subject agrees to comply with all protocol requirements.
4. The subject is able to provide written informed consent.
Additional inclusion criteria for Part 1:
1. The subject is male or female 18 to 55 years of age, inclusive.
2. The subject has a body weight =50 kg at screening and a BMI of 18 to 32 kg/m2,
inclusive, or.
3. The subject has a BMI of 30 to 40 kg/m2, inclusive, at screening in obesity subjects
cohort.
Additional inclusion criteria for Part 2:
1. The subject is male or female 18 to 60 years of age, inclusive.
2. The subject has a BMI of 30 to 45 kg/m2 at screening, inclusive.
3. Fasting triglyceride =150 mg/dL (1.7 mmol/L), and <500 mg/dL (5.7 mmol/L), at
screening.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. The subject has a positive test result for hepatitis B surface antigen, hepatitis C
virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
2. The subject has a personal or family history of medullary thyroid cancer, or multiple
endocrine neoplasia syndrome Type 2, or a screening calcitonin =50 ng/L.
3. The subject has a history of chronic pancreatitis or episode of acute pancreatitis
within 3 months of screening.
4. In Part 1, the subject has used any prescription medications (excluding oral
contraceptives, paracetamol, and ibuprofen) within 14 days before the first dose of
study drug. In Part 2, the subjects have been on stable lipid-lowering therapy <8
weeks before the first dose of study drug.
5. The subject has consumed alcohol within 48 hours before dosing or during the
confinement period.
6. The subject is a smoker or has used tobacco, nicotine, or nicotine-containing
products.
7. The subject has a history of alcohol abuse or drug addiction within the last year or
excessive alcohol consumption.
8. The subject has a positive test result for drugs of abuse and/or alcohol abuse at
screening and check-in for the first inpatient period.
9. The subject is involved in strenuous activity or contact sports within 48 hours before
admission.
10. The subject has donated blood or blood products >450 mL within 30 days before the
first dose of study drug.
11. The subject has total cholesterol >10.3 mmol/L or triglycerides =5.7 mmol/L (500
mg/dL) at screening.
12. The subject has clinically significant history or presence of ECG findings as
determined by the investigator at screening and check-in,
- Uncontrolled hypertension (defined as systolic blood pressure (SBP) =160 mmHg,
and/or diastolic blood pressure (DBP) =100 mmHg), angina, bradycardia (if assessed as
clinically significant by the investigator), or severe peripheral arterial circulatory
disorders.
13. The subject has a history of relevant drug and/or food allergies (ie, allergy to
DR10624 or excipients, or any significant food allergy that could preclude a standard
diet in the clinical unit).
14. The subject has a history of severe allergic or anaphylactic reactions.
15. The subject has experienced a >5% loss in body weight within 2 months prior to
screening.
16. Female subjects who are pregnant or lactating.
17. The subject has a positive test for severe acute respiratory syndrome corona virus 2
(SARS-CoV-2). A positive rapid antigen test (RAT), isothermal nucleic acid
amplification, or polymerase chain reaction (PCR) coronavirus disease-2019 (COVID-19)
test during screening or at admission is acceptable provided the subject has a known
previous COVID-19 infection =3 weeks prior to dosing, has recovered, and is now
asymptomatic
18. The subject has received study drug in another investigational study within 30 days of
dosing.
19. In the opinion of the investigator, the subject is not suitable for entry into the
study.
Additional exclusion criteria for subjects in Part 2:
1. Subjects with coagulopathies.
2. Poorly controlled diabetes, defined as HbA1c >8.5% at screening.
3. The subject has been treated with the following anti-diabetic agents, glucagon-like
peptide-1 receptor agonist (GLP-1Ra), dipeptidyl peptidase-4 inhibitors (DPP-4i), or
insulin, within 30 days prior to screening until the follow-up visit.
4. The subjects have >2 × upper limit of normal (ULN) of either alanine aminotransferase
(ALT) or aspartate aminotransferase (AST), or >1.5 × ULN for bilirubin or alkaline
phosphatase at screening.
5. Subjects with contraindications to MRI.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
104
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Canterbury
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Zhejiang Doer Biologics Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor
(GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing
activities. The objectives of the planned clinical investigation will be to evaluate the
safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and
multiple-ascending doses of DR10624 via subcutaneous (SubQ) injection in a randomized,
placebo-controlled, double-blind study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05378893
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alexandra Cole, DHPharm
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Address
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New Zealand Clinical Research (NZCR)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Senior Clinical Operations Director
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Address
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Country
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Phone
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+86 151 94 40 28 68
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05378893
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