Trial · Interventional

CompletedPhase 1Results postedRegistry data

Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

NCTNCT01473953Other idNN9223-3928Other idU1111-1123-0547

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 31 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Oct 2011
Primary completion: Mar 2012
Completion: Mar 2012
First posted: 17 Nov 2011 (estimated)
Last update posted: 23 Mar 2017
Conditions: Diabetes · Diabetes Mellitus, Type 2 · Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

Ph 1
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
NCT01473953
Oct 2011 to Mar 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.

Interventions

liraglutide-depotDrug
placeboDrug

Arms5

Experimental
Cohort 1a: Lira-depot 2.25 mg
Experimental
Cohort 2a: Lira-depot 6.75 mg
Experimental
Cohort 3a: Lira-depot 15 mg
Experimental
Cohort 4a: Lira-depot 30 mg
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Treatment Emergent Adverse Events (TEAEs)
Time frame · Day 0 and up to 21 days after treatment
Registry description
TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.

Secondary outcomes(6)

Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Time frame · Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Time frame · Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity
Time frame · Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment
Time frame · 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose
Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment
Time frame · 0 to 168 hours after dosing
Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up
Time frame · Day 0 and Day 21

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 0 and up to 21 days after treatment

Number of Treatment Emergent Adverse Events (TEAEs)

Group	Value (events)
Cohort 1a: Lira-depot 2.25 mg	3
Cohort 2a: Lira-depot 6.75 mg	3
Cohort 3a: Lira-depot 15 mg	4
Cohort 4a: Lira-depot 30 mg	21
Placebo	13

Secondary and other outcome results(6)

Secondary outcomeGeometric mean· Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose

Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot

Group	Value (pmol/L)	Spread
Cohort 1a: Lira-depot 2.25 mg	690	52
Cohort 2a: Lira-depot 6.75 mg	2141	25
Cohort 3a: Lira-depot 15 mg	6977	62
Cohort 4a: Lira-depot 30 mg	40041	35
Placebo	not posted	–

Secondary outcomeGeometric mean· Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose

Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot

Group	Value (hours)	Spread
Cohort 1a: Lira-depot 2.25 mg	15.13	92.28
Cohort 2a: Lira-depot 6.75 mg	8.09	55.78
Cohort 3a: Lira-depot 15 mg	13.74	22.13
Cohort 4a: Lira-depot 30 mg	10.46	24.62
Placebo	not posted	–

Secondary outcomeGeometric mean· Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose

Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity

Group	Value (pmol.h/L)	Spread
Cohort 1a: Lira-depot 2.25 mg	43840	24
Cohort 2a: Lira-depot 6.75 mg	116935	20
Cohort 3a: Lira-depot 15 mg	360000	46
Cohort 4a: Lira-depot 30 mg	1443038	22
Placebo	not posted	–

Secondary outcomeGeometric mean· 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose

Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment

Group	Value (pmol.h/L)	Spread
Cohort 1a: Lira-depot 2.25 mg	37298	27
Cohort 2a: Lira-depot 6.75 mg	114101	20
Cohort 3a: Lira-depot 15 mg	316642	46
Cohort 4a: Lira-depot 30 mg	1363187	21
Placebo	not posted	–

Secondary outcome· 0 to 168 hours after dosing

Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment

Group	Value
Cohort 1a: Lira-depot 2.25 mg	not posted
Cohort 2a: Lira-depot 6.75 mg	not posted
Cohort 3a: Lira-depot 15 mg	not posted
Cohort 4a: Lira-depot 30 mg	not posted
Placebo	not posted

Secondary outcomeNumber· Day 0 and Day 21

Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up

Group	Value (participants)
Cohort 1a: Lira-depot 2.25 mg	0
Cohort 2a: Lira-depot 6.75 mg	0
Cohort 3a: Lira-depot 15 mg	0
Cohort 4a: Lira-depot 30 mg	0
Placebo	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Cohort 1a: Lira-depot 2.25 mgIn cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.	–	0 / 6	3 / 6
Cohort 2a: Lira-depot 6.75 mgIn cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.	–	0 / 6	3 / 6
Cohort 3a: Lira-depot 15 mgIn cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.	–	0 / 6	3 / 6
Cohort 4a: Lira-depot 30 mgIn cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.	–	0 / 5	5 / 5
PlaceboIn the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).	–	0 / 8	5 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years up to 55 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Body mass index (BMI) between 20 and 35 kg/m\^2 (both inclusive) with a body weight of at least 60 kg * Apart from being obese (BMI above 30 kg/m\^2) the subject has to be considered generally healthy Exclusion Criteria: * Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders * Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy * Prescription medicine and non-prescription medicine with few exceptions * Current and prior history of alcohol or drug abuse * Current smoking of more than 5 cigarettes per day * Mental incapacity, language barriers, or unwillingness to comply with the protocol

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