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New Weight-Loss shot shows promise in major trial

NCT ID NCT06604624

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new weekly injection (HD1916) similar to semaglutide for weight loss in 462 obese adults without diabetes. Participants received the drug for 44 weeks, and researchers measured how much weight they lost and any side effects. The goal was to see if this treatment is safe and effective for managing obesity.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

462 people

The number who actually took part.

Started

Sep 2024

Finished

Sep 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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. Age ≥18 years old (at the time of signing ICF), both male and female; 2. BMI≥28 kg/m\^2 during screening; 3. Within 90 days before screening, the weight change range controlled by diet and exercise alone is less than 5% (see section 1.3 for the calculation formula); 4. Voluntarily participate in the trial and sign the informed consent. Exclusion Criteria: 1. Meet any of the following requirements: (1) HbA1c≥6.5% or fasting venous blood glucose ≥7.0 mmol/L during screening; (2) a history of type 1 or type 2 or a specific type of diabetes; 2. Obesity is caused by drugs or diseases (e.g. Cushing\'s syndrome, acromegaly, etc.); or weight gain caused by increased non-fat content (e.g. edema); 3. Received (including) drug therapy with GLP-1 receptor agonists (single target, double target, or multiple target) within 90 days prior to screening; 4. Received any other drug or product or treatment within 90 days prior to screening that the investigator determines will affect the assessment of weight efficacy of the trial, including but not limited to drugs or products or treatments that contain overweight/obesity or equivalent meaning in the label indications, hypoglycemic drugs, tricyclic antidepressants, antipsychotic or antiepileptic drugs (such as sodium valproate, citalopram, etc.), systemic use of glucocorticoids, etc.; 5. Previous bariatric metabolic surgery (except for previous liposuction, abdominal plastic surgery, intragastric balloon extraction or duodenal jejunal cannulation extraction \> 1 year), or planned to receive any surgical treatment during the trial that might affect the evaluation of weight efficacy; 6. Past allergy or suspected allergy to GLP-1 receptor agonists, or past allergy to investigational drug ingredients; 7. Participated in any other trial and received at least one treatment in the 90 days prior to screening; 8. Thyroid function is unstable or uncontrolled 90 days before screening, or TSH\> 6.0 mIU/L or \< 0.4 mIU/L at screening; 9. Previous or family history of medullary thyroid carcinoma or multiple endocrine adenomatosis type 2 (MEN-2) before screening; 10. Diagnosis of malignant tumors within 5 years prior to screening (except cured skin basal cell carcinoma or cervical carcinoma in situ); 11. Have any of the following major cardiovascular and cerebrovascular history in the 180 days prior to screening: history of myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or heart valve repair, clinically significant and treatment-requiring arrhythmia, unstable angina pectoris, decompensated cardiac insufficiency (NYHA Class III or IV), transient ischemic attack, cerebrovascular accident, etc.; 12. Serious gastrointestinal disease (e.g. abnormal gastric emptying, inflammatory bowel disease) before or during screening; 13. Patients with moderate to severe depression at the time of screening, or the total score of PHQ-9 at the time of screening ≥15 points; or history of other serious mental illness (e.g., schizophrenia, bipolar disorder); or have a history of suicidal thoughts, attempted suicide or suicidal behavior; 14. The presence of any of the following before or during screening: chronic pancreatitis, acute pancreatitis, symptomatic gallbladder disease (except cholecystectomy); 15. Any of the following items should be met during screening: (1) systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; (2) QTcF interval of ECG \>450 ms for male or \>470 ms for female; (3) eGFR\< 30 mL/min/1.73 m\^2, eGFR is calculated according to CKD-EPI formula; (4) ALT or AST \> 3× upper limit of normal value; (5) blood amylase or blood lipase \> 1.5× the upper limit of normal value; (6) blood triglyceride \> 5.7 mmol/L; (7) calcitonin ≥50ng/L (pg/mL); (8) HIV antibody or HCV antibody or HBsAg positive (except for HBsAg positive but HBV DNA quantitative test results are not higher than the upper limit of the test reference range and no anti-HBV drugs are used during screening); 16. A history of drug abuse, drug use or alcohol dependence; 17. Total blood donation ≥400 mL or one-time blood loss ≥400 mL within 90 days before screening; 18. Fertile female subjects are pregnant or lactating at the time of screening, or had positive HCG blood; or fertile male or female subjects and their partners are unable to use effective contraception during the trial period and within 3 months after the end of treatment; 19. Other situations in which the investigator does not consider participation in the study appropriate.

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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.

Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.