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Not yet recruitingNCT07841860Updated Sep 25, 2026

A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-1596 Tablets in Healthy Participants With a Single Dose and in Obese Participants With Multiple Doses

A Phase 1 interventional study of HRS-1596 and HRS-1596 Placebo in Weight Management and Type 2 Diabetes, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study is a randomized, double-blind, placebo-controlled, dose-escalation study that examines the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and multiple administrations in obese participants.

02

Conditions studied

  • Weight Management
  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 122 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 66 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily sign the 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 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

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 (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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
122 participants (estimated)

Study arms

  • Experimental
    HRS-1596 Group

    HRS-1596, healthy subjects or obese subjects.

    Drug: HRS-1596

  • Placebo comparator
    HRS-1596 Placebo Group

    HRS-1596 placebo, healthy subjects or obese subjects.

    Drug: HRS-1596 Placebo

Interventions

  • DrugHRS-1596

    HRS-1596.

  • DrugHRS-1596 Placebo

    HRS-1596 placebo.

06

What researchers measure

Primary outcomes

  1. The incidence and severity of adverse events (AEs)

    Time frame: Screening period up to Day 84.

Secondary outcomes

  1. The maximum plasma concentration (Cmax)

    Time frame: Post-dose at Day 1 to Day 84.

  2. Time to maximum plasma concentration (Tmax)

    Time frame: Post-dose at Day 1 to Day 84.

  3. Terminal half-life (t1/2)

    Time frame: Post-dose at Day 1 to Day 84.

  4. Anti-HRS-1596 Antibodies (ADAs)

    Time frame: Post-dose at Day 1 to Day 84.

  5. Fasting plasma glucose (FPG)

    Time frame: Post-dose at Day 1 to Day 84.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.

Of 452 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's planned 3 months is below that.

Counting every sponsor, half of 514 studies reached it within 6 months; a quarter within 2 and three quarters within 14.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2026
First posted
Sep 25, 2026
StartEst.
Sep 2026
Primary completionEst.
Dec 2026
CompletionEst.
May 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841860
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Xuehu Gao
Contact
xuehu.gao@hengrui.com
+86-0518-82342973
Jing He
Contact
jing.he@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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