Investigating the Bioavailability and Insulin-like Growth Factor-I Release of Two Different Strengths of Somapacitan: A Randomised, Double-Blind Crossover Trial.

Dombernowsky SL, Damholt BB, Højby Rasmussen M, Sværke C, Kildemoes RJ

Clinical pharmacokinetics5 Jul 2024Cited by 1 (Europe PMC)

PMID38969919PMCIDPMC11271340DOI10.1007/s40262-024-01395-yPepBankPUB-38969919

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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 study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialPharmacokinetics
In healthy participants, the somapacitan AUC ratio for the lower versus higher strength was 0.95, within bioequivalence limits.
In plain wordsIn healthy participants, total somapacitan exposure met bioequivalence limits for the lower versus higher strength.
Peptide
Somapacitan
Outcome
DecreaseAUC bioequivalence
Study
n = 33
Comparator
Somapacitan 10 mg/1.5 mL strength
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
AUC ratio
0.95
5 mg/1.5 mL versus 10 mg/1.5 mL
90% CI
0.89 to 1.01
Acceptance range
0.8 to 1.25
Source sentences
Summary
For AUC_0-t, estimated treatment ratio (ETR) (5 mg/1.5 mL versus 10 mg/1.5 mL) was 0.95 (90% confidence interval [CI] 0.89-1.01).
4 context sentences(design, population, supporting numbers)
Summary · context
Point estimate and 90% CIs were within the acceptance range (0.80-1.25).
Summary · context
Randomised, double-blind, crossover trial to confirm bioequivalence of somapacitan, a long-acting growth hormone (GH), in 5 mg/1.5 mL and 10 mg/1.5 mL strengths in equimolar doses.
Summary · context
Healthy participants were randomised (1:1:1) to subcutaneous somapacitan treatment in one dosing period with 5 mg/1.5 mL and two periods with 10 mg/1.5 mL.
Summary · context
Eligibility criteria included age 18-45 years and body mass index 18.5-24.9 kg/m².
Report a problemFND-3896991901
02HumanRandomized controlled trialPharmacokinetics
In healthy participants, the somapacitan maximum concentration ratio for the lower versus higher strength was 0.77, outside bioequivalence limits.
In plain wordsIn healthy participants, peak somapacitan concentration did not meet bioequivalence limits for the lower versus higher strength.
Peptide
Somapacitan
Outcome
DecreaseMaximum serum concentration bioequivalence
Study
n = 33
Comparator
Somapacitan 10 mg/1.5 mL strength
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Measurements
Cmax ratio
0.77
90% CI
0.68 to 0.89
Acceptance range
0.8 to 1.25
Source sentences
Summary
For C_max, ETR was 0.77 (90% CI 0.68-0.89).
4 context sentences(design, population, supporting numbers)
Summary · context
Point estimate and 90% CIs were outside the acceptance range (0.80-1.25).
Summary · context
Randomised, double-blind, crossover trial to confirm bioequivalence of somapacitan, a long-acting growth hormone (GH), in 5 mg/1.5 mL and 10 mg/1.5 mL strengths in equimolar doses.
Summary · context
Healthy participants were randomised (1:1:1) to subcutaneous somapacitan treatment in one dosing period with 5 mg/1.5 mL and two periods with 10 mg/1.5 mL.
Summary · context
Eligibility criteria included age 18-45 years and body mass index 18.5-24.9 kg/m².
Report a problemFND-3896991902
03HumanRandomized controlled trialEfficacy outcome
In healthy participants, mean IGF-I concentration-time curves were almost identical between somapacitan strengths.
In plain wordsIn healthy participants, IGF-I concentration curves were almost identical between the lower and higher somapacitan strengths.
Peptide
Somapacitan
Outcome
No significant changeIGF-I concentration-time curve
Study
n = 33
Comparator
Somapacitan 10 mg/1.5 mL strength
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Mean insulin-like growth factor-I (IGF-I) and IGF-I standard deviation score concentration-time curves for each strength were almost identical.
3 context sentences(design, population, supporting numbers)
Summary · context
Randomised, double-blind, crossover trial to confirm bioequivalence of somapacitan, a long-acting growth hormone (GH), in 5 mg/1.5 mL and 10 mg/1.5 mL strengths in equimolar doses.
Summary · context
Healthy participants were randomised (1:1:1) to subcutaneous somapacitan treatment in one dosing period with 5 mg/1.5 mL and two periods with 10 mg/1.5 mL.
Summary · context
Eligibility criteria included age 18-45 years and body mass index 18.5-24.9 kg/m².
Report a problemFND-3896991903
04HumanRandomized controlled trialEfficacy outcome
In healthy participants, IGF-I standard deviation score concentration-time curves were almost identical between somapacitan strengths.
In plain wordsIn healthy participants, IGF-I score curves were almost identical between the lower and higher somapacitan strengths.
Peptide
Somapacitan
Outcome
No significant changeIGF-I SDS concentration-time curve
Study
n = 33
Comparator
Somapacitan 10 mg/1.5 mL strength
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
Mean insulin-like growth factor-I (IGF-I) and IGF-I standard deviation score concentration-time curves for each strength were almost identical.
3 context sentences(design, population, supporting numbers)
Summary · context
Randomised, double-blind, crossover trial to confirm bioequivalence of somapacitan, a long-acting growth hormone (GH), in 5 mg/1.5 mL and 10 mg/1.5 mL strengths in equimolar doses.
Summary · context
Healthy participants were randomised (1:1:1) to subcutaneous somapacitan treatment in one dosing period with 5 mg/1.5 mL and two periods with 10 mg/1.5 mL.
Summary · context
Eligibility criteria included age 18-45 years and body mass index 18.5-24.9 kg/m².
Report a problemFND-3896991904
05HumanNon-randomized trialSafety outcome
In healthy participants receiving somapacitan, no new safety issues were identified.
In plain wordsIn healthy participants receiving somapacitan, no new safety issues were identified.
Peptide
Somapacitan
Outcome
Not applicableNew safety issues
Study
n = 33
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneousAs given in this study (human).
Source sentences
Summary
No new safety issues were identified.
3 context sentences(design, population, supporting numbers)
Summary · context
Randomised, double-blind, crossover trial to confirm bioequivalence of somapacitan, a long-acting growth hormone (GH), in 5 mg/1.5 mL and 10 mg/1.5 mL strengths in equimolar doses.
Summary · context
Healthy participants were randomised (1:1:1) to subcutaneous somapacitan treatment in one dosing period with 5 mg/1.5 mL and two periods with 10 mg/1.5 mL.
Summary · context
Eligibility criteria included age 18-45 years and body mass index 18.5-24.9 kg/m².
Report a problemFND-3896991905

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

Registered trials1

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

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT03905850

A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects

Novo Nordisk A/Sn = 3329 Mar 2019 to 15 Jul 2019

Healthy Volunteers · Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 6 Aug 2019

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.

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