New Weight-Loss drug tested in kidney patients
NCT ID NCT07559240
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study will test a single dose of the experimental drug HDM1005 in 30 overweight or obese adults, some with moderate or severe kidney disease and some with healthy kidneys. The goal is to see how kidney function affects the drug's levels in the body and to check for safety issues. This is a Phase 1 trial, meaning it's one of the first steps in human testing, so it's focused on safety and drug processing rather than weight loss itself.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HDM1005 injection
- What this could lead to
- If successful, this study could help determine safe dosing of HDM1005 for people with kidney problems, potentially leading to a weight management option for this group.
- What could go wrong
- This is a very early Phase 1 study with only 30 participants, so results may not apply broadly. The drug may not work as expected or could have side effects, especially in those with kidney impairment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged between 18 and 75 years (inclusive), regardless of gender. * Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive). * For participants with renal impairment: prior diagnosis of chronic kidney disease (CKD). Absolute GFR calculated by CKD-EPI and BSA formula: ≥30 and \<60 mL/min for moderate impairment; ≥15 and \<30 mL/min for severe impairment. * For participants with normal renal function: aged 18 to 75 years (inclusive); body weight ≥50.0 kg (male) or ≥45.0 kg (female); BMI 19.0-35.0 kg/m². * In the investigator's opinion, suitable for the study based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening. * Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions. * Able to communicate well with the investigator and understand and comply with all study requirements. Exclusion Criteria: * Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2). * History of chronic pancreatitis, or an episode of acute pancreatitis or acute cholecystitis within 3 months prior to screening. * Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening. * For the renal impairment group: presence of obstructive urinary tract disease, acute kidney injury, or other clinically significant systemic diseases beyond chronic kidney disease and its complications, which in the investigator's opinion make the participant unsuitable. For the normal renal function group: presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable. * Known intolerance or allergy to GLP-1R and/or GIPR agonists, or known allergy to HDM1005 or any component of the formulation. * Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study. * Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing. * History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, methylenedioxymethamphetamine, cocaine) or positive urine drug test at screening. * History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture. * Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
Beijing, 100191, China
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