A study in adults who are overweight or obese to assess the safety and effects of a new injectable medicine (PN-477)

A randomized, double-blind, placebo-controlled single-ascending dose study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous PN-477 in obese or overweight adult participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12731732

Enrollment

Registered

2026-06-05

Start date

2026-07-24

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, obese Nutritional, Metabolic, Endocrine

Interventions

This is a randomized, double-blind, single-ascending dose study to assess the safety, tolerability, PK and PD of single ascending doses of PN-477. The study consists of 5 planned subcutaneous dosing c

n=1 placebo). Randomisation: Participants will be assigned a unique randomization number and receive their treatment according to a paper randomization schedule that will be provided to the unblinded

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 65 years 2. Men and women who are overweight or obese (BMI between 25 and 40 kg/m²) with a stable body weight for at least 3 months 3. Generally healthy, with no major medical problems based on medical history, physical examination, heart tests, and blood tests 4. Normal or acceptable blood test results, including sugar levels, liver and kidney function, and cholesterol, as assessed by the study doctor 5. Not pregnant or breastfeeding, and willing to use reliable birth control during the study and for a period after the last dose 6. Willing and able to understand the study, sign the consent form, and attend all required study visits

Exclusion criteria

Exclusion criteria: 1. Current or past serious medical conditions involving the heart, lungs, liver, kidneys, stomach, intestines, hormones, nervous system, mental health, blood, immune system, or skin 2. Cancer within the past 5 years, except for certain early, fully treated cancers 3. Recent surgery, serious infection, or fever 4. Abnormal blood pressure, heart rate, or heart rhythm test results 5. Severe allergies, serious drug reactions, or sensitivity to the study medicine or its ingredients 6. Use of recreational drugs, excessive alcohol intake, or heavy smoking or nicotine use 7. Recent large blood donation, significant blood loss, or blood transfusion 8. Recent participation in another clinical trial or recent use of an investigational drug or device 9. Inability or unwillingness to follow study instructions or considered unsuitable by the study doctor

Countries

Australia

Contacts

Public ContactAndrew Redfern

Andrew.Redfern@health.wa.gov.au+61 08 6382 5100

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026