Clinical pharmacology · Phase 1
Zenagamtide: renal function and drug exposure
What was tested?
A single subcutaneous exposure to zenagamtide, formerly amycretin, in groups with differing renal function; no placebo group. ↗
Registered primary question: Total drug exposure, measured as area under the concentration-time curve from time zero to infinity, using samples collected through day 28. ↗
What the reviewed report found
Journal year 2026 · Article summary reviewed 2026-09-15
The authors reported broadly comparable exposure measurements across groups. Treatment-emergent adverse events occurred in 30 of 42 participants; none were serious or severe, and most were mild gastrointestinal events.↗
Keep in context: The 42 participants were divided among five renal-function groups. This short pharmacokinetic study does not establish treatment benefit, long-term safety or a dosing recommendation. ↗↗
What a closer reading adds
Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.
Exposure differences need interpretation
Adjusted total-exposure estimates were higher in the renal-impairment groups. The authors judged those differences not clinically relevant, but the study was not powered for a statistical comparison of pharmacokinetic parameters. Their interpretation should not be read as proof of identical exposure. Full text ↗ · Indexed abstract ↗
Sections: Endpoints and Statistical Analysis; Pharmacokinetics; Discussion.
A short observation in small groups
All 42 participants completed follow-up, with 14 in the normal-function group and seven in each renal-impairment group. No serious treatment-emergent events were reported through day 28. The small sample, single exposure and predominantly White population limit conclusions about longer-term use and broader populations. Full text ↗ · Indexed abstract ↗
Sections: Results; Safety; Discussion.
Participants, design, limitations and sources
Registry snapshot
- Registry enrollment
- 42 · reported actual
- Registry status
- Completed
- Allocation and masking
- Non randomized · Open label
- Design
- Parallel
- Eligible ages
- 18 Years to 80 Years
- Registry results
- Not posted in this snapshot
Registry source ↗ · Updated 2025-03-30; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.
Renal-function pharmacokinetic study
- Design in the report
- A single-exposure study compared pharmacokinetics across renal-function groups with four weeks of follow-up, registered as NCT06559527.↗
- Participants in the report
- Forty-two adults participated: 14 with normal renal function and seven each with mild, moderate or severe impairment or end-stage renal disease.↗
- Limitations
- Small groups, one exposure and short follow-up do not establish long-term safety or therapeutic benefit in people with kidney disease. The report does not support individualized treatment recommendations.↗
This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →
How the study identity and sources were checked
Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.
Registry
A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function ↗
Protocol identifier: NN9490-7611. Sponsor: Novo Nordisk A/S.
Retrieved 2026-09-20; SHA-256 9197b1106c60488e2ce9f363575f00a70b5187ec640c7f22990f28ed287bf149.
PMID 42443140
Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide. ↗
Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.
Identity metadata retrieved 2026-09-20. EFetch batch XML; locate MedlineCitation/PMID 42443140. SHA-256 adc8edd8b150d99a3641ddbc74c59db6916cf35d9d6246838aaff2cc195ae1cb.
Scientific summary uses the original 2026-09-15 source snapshot: SHA-256 56ff4122a6898bfea6b5969ea65ecd7c4cef6fc282cb69818c791eaba39ba5c6.
Selected full text: PMC13538736
Renal Impairment Does Not Affect Pharmacokinetics, Safety or Tolerability of Zenagamtide ↗
Retrieved 2026-09-20; SHA-256 846ff8cc4fd376b6c09ad3bdbd69c7749f60d40fecc9caababfff8f7d1dce76f. Section identifiers and hashes are included in the cited study data.