A new pill aims at weight and blood sugar
NCT ID NCT07841860
First seen Sep 25, 2026 · Last updated Sep 25, 2026
Summary
Researchers are testing an experimental tablet called HRS-1596 to see if it is safe and how the body processes it. The trial gives single doses to healthy adults and multiple doses to adults with obesity. Participants receive either HRS-1596 or a placebo, and researchers track side effects, drug levels in the blood, and early signs of effect on blood sugar.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental tablet called HRS-1596
- What this could lead to
- If HRS-1596 proves safe and behaves well in the body, it could become a future pill option for weight management and type 2 diabetes.
- What could go wrong
- This is a first-in-human phase 1 trial with 122 participants, so most drugs at this stage fail or need years more testing. Side effects may appear, and the drug may not work well enough in larger studies.
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 122 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
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 55 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: 1. Voluntarily sign the informed consent form before the commencement of the activities related to this trial, and be able to understand the procedures and methods of this trial. Also, be willing to strictly follow the clinical trial protocol to complete this trial. 2. The age range is from 18 to 55 years old (inclusive at both ends). 3. Weight ≥ 50.0 kg. 4. They must also not be in the lactation period. For male participants whose partners are fertile women, they must agree to voluntarily adopt medically approved highly effective contraceptive measures from the time of signing the informed consent form until 2 months after the last administration. They must have no intention to have children and must avoid donating sperm/eggs (including their partners). Exclusion Criteria: 1. During the screening process, systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg were considered. 2. The score of the Patient Health Questionnaire-9 (PHQ-9) during screening was ≥ 15 points. 3. During the screening process, there may be cases where there are obvious endocrine diseases or medical histories that could significantly affect body weight (such as Cushing's syndrome, hypothyroidism or hyperthyroidism, etc.), or obesity caused by single gene mutations or hereditary obesity syndromes, etc. 4. Diabetes (except gestational diabetes). 5. Any malignant tumor of any organ system has occurred within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis (except for cured local basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ). 6. Those who have had or currently have the following diseases with clinical significance (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cardiovascular diseases), and who, in the judgment of the investigators, are not suitable to participate in this trial. 7. Those who consumed more than 14 units of alcohol per week within the previous 6 months (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol content spirits or 150 mL of wine); or those who had taken any alcohol-containing products within 48 hours before the administration; or those with a positive alcohol breath test result. 8. Screening criteria: Daily smoking quantity greater than 5 cigarettes within the past 3 months or use of any tobacco product within 48 hours prior to administration. 9. Those with a known or suspected history of drug abuse or drug use; or those with a positive urine drug screening result. 10. Unable to tolerate venipuncture for blood collection or experiencing fainting or nausea during the procedure.
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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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Jinan Central Hospital
Jinan, Shandong, 250013, China
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Other studies related to the condition(s) this trial covers.
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