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Overweight and Obese Adults / Placebo, solution for injection / First in Man Study to Evaluate Initial Safety · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a first-in-human, Phase 1 ascending-dose trial of the investigational drug ZP6590 in healthy and overweight/obese adults. The study is designed to establish safety, tolerability, and pharmacokinetic properties but is still recruiting and has not yet reported results.
Early Phase 1, Interventional, Randomized, Sequential, Triple masking, Treatment purpose. Healthy Participants Study, Overweight and Obese Adults, First in Man Study to Evaluate Initial Safety; Male; age from 18 Years; to 60 Years; accepts healthy volunteers. Intervention: Drug: ZP6590, solution for injection. Compared with: Placebo, solution for injections — Placebo Comparator. n = 88. 1 site: Germany.
This is a first-in-human, Phase 1 ascending-dose trial of the investigational drug ZP6590 in healthy and overweight/obese adults. The study is designed to establish safety, tolerability, and pharmacokinetic properties but is still recruiting and has not yet reported results.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a first-in-human Phase 1 trial registration with no results posted; it is early-stage safety and pharmacokinetic work designed to establish initial tolerability and drug behavior.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07721597). This is a study registration, not published results. Lead sponsor: Zealand Pharma. Recruitment status: RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 88 participants (ESTIMATED). Conditions: Healthy Participants Study, Overweight and Obese Adults, First in Man Study to Evaluate Initial Safety. Interventions: DRUG: ZP6590, solution for injection; DRUG: Placebo, solution for injection. Primary outcome measures: Safety and Tolerability , Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120. Brief summary: The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are: * Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590? * How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body? In the first Part of the study: Participants will: • Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks. In the second Part of the study: Participants will: • Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.