Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials.

Bentz Damholt B, Dombernowsky SL, Dahl Bendtsen M, Bisgaard C, Højby Rasmussen M

Clinical pharmacokinetics23 Mar 2021Cited by 4 (Europe PMC)

PMID33754315PMCIDPMC8332591DOI10.1007/s40262-021-00990-7PepBankPUB-33754315

Read at source PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialSafety outcome
In adults without GHD receiving somapacitan in kidney and hepatic impairment trials, no new safety or tolerability issues were observed.
In plain wordsIn adults without GHD, somapacitan trials in kidney and liver impairment found no new safety or tolerability issues.
Peptide
Somapacitan
Outcome
Not applicableSafety and tolerability
Study
n = 78
Outcome group
Adverse events · Whole body
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Source sentences
Summary
No new safety or tolerability issues were observed.
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431509
02HumanObservational studyPharmacokinetics
In adults without GHD, severe kidney impairment was linked to higher somapacitan AUC versus normal function (ratio 1.75, 90% CI 1.00-3.06).
In plain wordsIn adults without GHD, severe kidney impairment was linked to higher somapacitan exposure than normal kidney function.
Peptide
Somapacitan
Outcome
IncreaseSomapacitan AUC, severe kidney impairment
Study
n: not reported in source
Comparator
Normal kidney function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
Somapacitan AUC0-168h ratio
1.75 ratio
Severe kidney impairment vs normal kidney function
90% CI
1 to 3.06 ratio
Severe kidney impairment vs normal kidney function
Source sentences
Summary
In the kidney impairment trial, somapacitan AUC_0-168 h was higher in groups with severe kidney impairment and requiring hemodialysis versus the normal kidney function group (estimated ratio and 90% confidence interval 1.75 [1.00-3.06] and 1.63 [1.01-2.61], respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431501
03HumanObservational studyPharmacokinetics
In adults without GHD, hemodialysis status was linked to higher somapacitan AUC versus normal function (ratio 1.63, 90% CI 1.01-2.61).
In plain wordsIn adults without GHD, hemodialysis status was linked to higher somapacitan exposure than normal kidney function.
Peptide
Somapacitan
Outcome
IncreaseSomapacitan AUC, hemodialysis
Study
n: not reported in source
Comparator
Normal kidney function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
Somapacitan AUC0-168h ratio
1.63 ratio
Hemodialysis vs normal kidney function
90% CI
1.01 to 2.61 ratio
Hemodialysis vs normal kidney function
Source sentences
Summary
In the kidney impairment trial, somapacitan AUC_0-168 h was higher in groups with severe kidney impairment and requiring hemodialysis versus the normal kidney function group (estimated ratio and 90% confidence interval 1.75 [1.00-3.06] and 1.63 [1.01-2.61], respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431502
04HumanObservational studyPharmacokinetics
In adults without GHD, moderate hepatic impairment was linked to significantly higher somapacitan AUC (ratio 4.69, interval 2.92-7.52) versus normal function.
In plain wordsIn adults without GHD, moderate liver impairment was linked to higher somapacitan exposure than normal liver function.
Peptide
Somapacitan
Outcome
IncreaseSomapacitan AUC, moderate hepatic impairment
Study
n: not reported in source
Comparator
Normal hepatic function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
Somapacitan AUC0-168h ratio
4.69 ratio
Moderate hepatic impairment vs normal hepatic function
Interval
2.92 to 7.52 ratio
Moderate hepatic impairment vs normal hepatic function
Source sentences
Summary
In the hepatic impairment trial, somapacitan AUC_0-168 h was significantly higher in the moderate impairment group compared with the normal hepatic function group (4.69 [2.92-7.52]).
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431506
05HumanObservational studyPharmacokinetics
In adults without GHD, moderate kidney impairment was linked to higher IGF-I AUC after somapacitan (ratio 1.35, interval 1.09-1.66).
In plain wordsIn adults without GHD, moderate kidney impairment was linked to higher IGF-I exposure after somapacitan than normal kidney function.
Peptide
Somapacitan
Outcome
IncreaseIGF-I AUC, moderate kidney impairment
Study
n: not reported in source
Comparator
Normal kidney function
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
IGF-I AUC0-168h ratio
1.35 ratio
Moderate kidney impairment vs normal kidney function
Interval
1.09 to 1.66 ratio
Moderate kidney impairment vs normal kidney function
Source sentences
Summary
AUC_0-168 h of IGF-I was increased in the moderate impairment group (1.35 [1.09-1.66]), severe impairment group (1.40 [1.10-1.78]), and requiring hemodialysis group (1.24 [1.01-1.52]), compared with the normal function group.
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431503
06HumanObservational studyPharmacokinetics
In adults without GHD, severe kidney impairment was linked to higher IGF-I AUC after somapacitan (ratio 1.40, interval 1.10-1.78).
In plain wordsIn adults without GHD, severe kidney impairment was linked to higher IGF-I exposure after somapacitan than normal kidney function.
Peptide
Somapacitan
Outcome
IncreaseIGF-I AUC, severe kidney impairment
Study
n: not reported in source
Comparator
Normal kidney function
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
IGF-I AUC0-168h ratio
1.4 ratio
Severe kidney impairment vs normal kidney function
Interval
1.1 to 1.78 ratio
Severe kidney impairment vs normal kidney function
Source sentences
Summary
AUC_0-168 h of IGF-I was increased in the moderate impairment group (1.35 [1.09-1.66]), severe impairment group (1.40 [1.10-1.78]), and requiring hemodialysis group (1.24 [1.01-1.52]), compared with the normal function group.
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431504
07HumanObservational studyPharmacokinetics
In adults without GHD, hemodialysis status was linked to higher IGF-I AUC after somapacitan (ratio 1.24, interval 1.01-1.52).
In plain wordsIn adults without GHD, hemodialysis status was linked to higher IGF-I exposure after somapacitan than normal kidney function.
Peptide
Somapacitan
Outcome
IncreaseIGF-I AUC, hemodialysis
Study
n: not reported in source
Comparator
Normal kidney function
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
IGF-I AUC0-168h ratio
1.24 ratio
Hemodialysis vs normal kidney function
Interval
1.01 to 1.52 ratio
Hemodialysis vs normal kidney function
Source sentences
Summary
AUC_0-168 h of IGF-I was increased in the moderate impairment group (1.35 [1.09-1.66]), severe impairment group (1.40 [1.10-1.78]), and requiring hemodialysis group (1.24 [1.01-1.52]), compared with the normal function group.
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431505
08HumanObservational studyPharmacokinetics
In adults without GHD, mild hepatic impairment was linked to lower IGF-I AUC after somapacitan (ratio 0.85, interval 0.67-1.08) versus normal function.
In plain wordsIn adults without GHD, mild liver impairment was linked to numerically lower IGF-I exposure after somapacitan than normal liver function.
Peptide
Somapacitan
Outcome
DecreaseIGF-I AUC, mild hepatic impairment
Study
n: not reported in source
Comparator
Normal hepatic function
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
IGF-I AUC0-168h ratio
0.85 ratio
Mild hepatic impairment vs normal hepatic function
Interval
0.67 to 1.08 ratio
Mild hepatic impairment vs normal hepatic function
Source sentences
Summary
IGF-I AUC_0-168 h was lower in both hepatic impairment groups (0.85 [0.67-1.08] for the mild impairment group and 0.75 [0.60-0.95] for the moderate impairment group) compared with the normal function group.
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431507
09HumanObservational studyPharmacokinetics
In adults without GHD, moderate hepatic impairment was linked to lower IGF-I AUC after somapacitan (ratio 0.75, interval 0.60-0.95) versus normal function.
In plain wordsIn adults without GHD, moderate liver impairment was linked to lower IGF-I exposure after somapacitan than normal liver function.
Peptide
Somapacitan
Outcome
DecreaseIGF-I AUC, moderate hepatic impairment
Study
n: not reported in source
Comparator
Normal hepatic function
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.08 mg/kg on days 1, 8, and 15 · subcutaneousAs given in this study (human).
Measurements
IGF-I AUC0-168h ratio
0.75 ratio
Moderate hepatic impairment vs normal hepatic function
Interval
0.6 to 0.95 ratio
Moderate hepatic impairment vs normal hepatic function
Source sentences
Summary
IGF-I AUC_0-168 h was lower in both hepatic impairment groups (0.85 [0.67-1.08] for the mild impairment group and 0.75 [0.60-0.95] for the moderate impairment group) compared with the normal function group.
2 context sentences(design, population, supporting numbers)
Summary · context
Subjects with normal kidney/hepatic function were matched to those with kidney/hepatic impairment by age, sex, and body weight.
Summary · context
Subjects received three subcutaneous somapacitan administrations (0.08 mg/kg) on days 1, 8, and 15.
Report a problemFND-3375431508

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT03212131

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

Novo Nordisk A/Sn = 3416 Aug 2017 to 8 Mar 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 24 May 2019

CompletedPhase 1NCT03186495

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Novo Nordisk A/Sn = 4420 Jun 2017 to 17 May 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 17 Apr 2020

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.