New daily pill could help shed pounds without injections
NCT ID NCT06953063
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new daily pill called DA-302168S in 250 overweight or obese adults. The pill works like a natural hormone to control appetite. Researchers measured weight loss and side effects over 16 weeks. The goal is to see if this pill is a safe and effective option for weight management.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DA-302168S (a daily pill that mimics a natural hormone to help control appetite and weight)
- What this could lead to
- If successful, this could lead to a new once-daily pill for weight management in people with obesity or overweight.
- What could go wrong
- This is an early Phase 2 trial with only 250 participants, so results may not apply to everyone. The pill may cause side effects or fail to show meaningful weight loss compared to placebo.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
250 people
The number who actually took part.
- Started
-
May 2025
- Finished
-
Dec 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 to 75 years
- 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 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. Age range:18-75 years old (inclusive),regardless of gender; 2. BMI requirements at screening:obese patients, BMI \>28 kg/m2 with or without comorbidities; or, overweight patients, BMI =24.0 kg/m2 but 28 kg/m2 with at least one; 3. Weight change (weight change \[maximum weight-minimum weight\] /maximum weight;based on subject self-report)did not exceed 5%during the 3 months before screening under diet and exercise control; Exclusion Criteria: 1. Secondary obesity: including obesity previously diagnosed as endocrine disease or caused by single gene mutation (including but not limited to hypothalamic obesity, pituitary obesity, Cushing's syndrome, hypothyroidism, islet cell tumor, acromegaly, hypogonadism, polycystic ovary syndrome, etc.) or drug-induced obesity (such as glucocorticoids, tricyclic antidepressants, atypical antipsychotics, etc.) 2. Those who have undergone weight loss surgery in the past (except for acupuncture weight loss, liposuction and abdominal fat removal surgery one year before screening), or plan to undergo surgery for obesity during the study period, such as gastric bypass, gastric banding, etc.; 3. The patient has clinically cardiovascular and cerebrovascular diseases, including but not limited to the following cardiovascular and cerebrovascular diseases or conditions within 6 months before signing the ICF: a. Unstable angina pectoris; b. Heart failure (New York Heart Association heart function grade III or IV); c. Myocardial infarction; d. Coronary artery bypass grafting or percutaneous coronary intervention; e. Uncontrolled severe arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block, etc.; f. Cerebrovascular accident, such as cerebral infarction, transient ischemic attack, etc. 4. Those who had acute pancreatitis 3 months before signing the ICF, or had a history of chronic pancreatitis or pancreatic injury, which may be high-risk factors for pancreatitis; 5. Individuals who have experienced acute cholecystitis in the 3 months prior to signing the ICF, or have cholecystitis/cholangitis/bile duct stones/multiple gallstones at screening, or have been assessed by researchers as having gallbladder-related diseases that may lead to a high incidence of cholecystitis during screening; 6. Sufering from any malignant tumor within 5 years before signing the ICF (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix); 7. A history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; 8. Patients with a history of thyroid dysfunction who still require medication during screening, or with clinically significant abnormal thyroid function results during screening, or with thyroid nodules assessed by researchers as having safety risks during screening.; 9. Those who have experienced severe hypoglycemia or repeated symptomatic hypoglycemia (≥2 times within half a year) in the past (severe hypoglycemia is defined as: severe events accompanied by changes in consciousness and/or body, hypoglycemia that requires help from others); 10. Those with a specific allergy history that, as assessed by the investigator, will significantly affect the safety of the subjects (such as asthma, urticaria, eczema, etc.) or allergic constitution, or those who are allergic to any component of the trial drug or preparation, or those who are allergic to other glucagon-like peptide-1 receptor agonist (GLP-1RA) drugs or drugs with a glucagon-like peptide-1 (GLP-1) receptor stimulating mechanism; 11. HbA1c ≥ 6.5%, or FPG ≥ 7.0 mmol/L or ≤ 3.9 mmol/L at screening, or patients previously diagnosed with type 1 diabetes, type 2 diabetes, or other special types of diabetes (according to the diabetes diagnosis and classification criteria issued by the World Health Organization \[WHO\] in 2019; 12. Those with a history of moderate to severe depression, anxiety, or severe mental illness, or those with a depression screening scale (PHQ-9) score ≥ 15 at screening (see Appendix 3 for details); 13 Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including but not limited to gastrectomy or any intestinal resection, severe gastrointestinal disease, clinically obvious gastric emptying abnormalities, etc.; 14.People who are lactose intolerant (for example, those who have had diarrhea after drinking milk within the shelf life); 15.During screening, the clinical laboratory test (local laboratory) results showed any of the following abnormalities (rechecked and confirmed once within 1 week if necessary): 1) hemoglobin \<100 g/L for females and \<110 g/L for males; alanine aminotransferase (ALT) ≥2.0×upper limit of normal (ULN); 2) aspartate aminotransferase (AST) ≥2.0×ULN; 3) total bilirubin (TBIL) ≥1.5×ULN; 4) blood amylase or blood lipase \>1.5×ULN; 5) calcitonin ≥1.0×ULN; 6) estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 \[Chronic Kidney Disease Epidemiology Institute (CKD-EPI) formula, see Appendix 4 for details\]; 7) TG \>500 mg/dl (5.65 mmol/L); 8) thyroid stimulating hormone \>6 mIU/L or \<0.4 mIU/L; 16.Uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg; 17.During screening, 12-lead ECG examinations were performed three times in the supine position at rest, and the average corrected QT interval (corrected according to Fridericia's formula, see Appendix 5 for details) obtained from the three measurements was \>450 msec; 18.Those with a history of drug abuse in the past five years or who had used drugs in the three months before screening; 19 Received any GLP-1 RA before screening (including GLP-1R agonists, GLP-1R related multitarget agonists, or compound preparations containing GLP-1R agonists, etc.); 20.Female subjects who are pregnant or breastfeeding, or have a positive pregnancy test; 21.Drugs that may affect body weight were used within 3 months before screening, including: dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulin, metformin, insulin secretagogues, or thiazolidinedione (TZD) and other hypoglycemic drugs; any approved or unapproved weight loss drugs, such as orlistat, Lorcaserin, phentermine/topiramate, naltrexone/bupropion, etc.) or Chinese herbal medicines, health products, meal replacements, etc. that affect body weight; systemic steroid hormones (intravenous, oral or intra-articular); tricyclic antidepressants, antipsychotics or anti-epileptic drugs (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts), etc.; Note: Except for those who have used systemic hormones for less than 7 days cumulatively or continuously; 22.Active autoimmune diseases (such as lupus, rheumatoid arthritis), who may be treated with systemic glucocorticoids during the study period as determined by the investigator; 23.Participants who have participated in clinical trials of other drugs within the previous 3 months and received the investigational drug (excluding those who received a placebo); 24. Those who donated blood or lost ≥400 mL of blood, received blood transfusion, or used blood products within 3 months before screening; 25 Heavy smokers or those who smoked ≥5 cigarettes per day on average within 3 months before screening; 26 Heavy drinkers or regular drinkers within 3 months before screening, that is, drinking more than 14 standard units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of 40% alcohol liquor or 150 mL of wine); 27 Patients with positive results in any of the tests for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab)or Treponema pallidum antibody (TP-Ab); patients with hepatitis B who are HBsAg negative but are undergoing antiviral treatment; 28 The investigator believes that there are other factors that may affect the evaluation of relevant indicators of the effectiveness and safety of this study and make the subject unsuitable for participation in this clinical trial (including but not limited to the investigator's judgment that the subject's compliance is poor, or the subject lives too far away and cannot be followed up as scheduled, etc.)
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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, China
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