Overweight and ObesityPhase 1DA168NCT06541730
A Study Evulating DA-302168S Tablets in Overweight/Obese Subjects
A Phase 1 study testing DA-302168S in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of continuous oral administration of DA-302168S tablets for 28 days in overweight/obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- DA-302168S
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to 30 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18~60 years old, male and female.
- Weight: male ≥50 kg, female ≥45 kg, body mass index (BMI) in the range of 24.0 to 35.0 kg/m2.
- Stable weight in the 3 months prior to screening (self-reported weight change less than 5%).
- Subject and his or her spouse or partner did not plan to become pregnant or plan to donate sperm or ovums from 14 days prior to screening to 3 months after the last dose, and agreed to use at least one acceptable method of effective contraception.
- Written informed consent prior to any study specific procedures.
Who cannot join
- Subjects with secondary obesity, such as obesity caused by metabolic diseases (such as Cushing's syndrome, decreased thyroid function, etc.) or drug-induced obesity (such as glucocorticoids, tricyclic antidepressants, atypical antipsychotics, etc.)
- Subjects with clinically significant cardiovascular and cerebrovascular diseases, including a history of angina pectoris, myocardial infarction, stroke or severe peripheral arterial circulation disorder, or transient ischemic attack within 1 year before signing the ICF; There are risk factors for tip torsion ventricular tachycardia. The presence of untreated severe arrhythmias, such as sick sinus syndrome, second or third degree atrioventricular block; New York Heart Association Heart Function Class II-IV heart failure.
- Previous history or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2;
- Subjects with acute pancreatitis or acute cholecystitis within 3 months before signing the ICF, or with chronic pancreatitis in the past, a history of symptomatic gallbladder (such as multiple gallstones, etc.), or a history of pancreatic injury and other high-risk factors that may lead to pancreatitis;
- Had any malignancy within 5 years prior to signing the ICF (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- The presence of concomitant diseases, including but not limited to diseases of the respiratory system, digestive system, nervous system, genitourinary system, blood system, endocrine system, etc. that are determined by the investigator to affect the safety of the subject or the findings of the study;
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- Those who had previously undergone weight loss surgery (excluding acupuncture for weight loss, liposuction and abdominal fat removal 1 year before screening) or planned to undergo surgery for obesity during the study period, such as gastric bypass or gastric banding;
- Subjects who have experienced severe hypoglycemia or recurrent symptomatic hypoglycemia (≥2 times within half a year) in the past;
- Subjects who have a history of specific allergies (asthma, urticaria, eczema, etc.) or allergies, or are allergic to any component of the investigatory drug or preparation, or are allergic to other GLP-1RA drugs or drugs that have a mechanism of activating GLP-1 receptor;
- HbA1c≥6.5%, or fasting blood glucose ≥7.0 mmol/L or ≤3.9 mmol/L at screening period, or previously diagnosed with type 1 diabetes, type 2 diabetes, or other specific type of diabetes;
- Subjects with a history of thyroid dysfunction who still need drug therapy at screening, or abnormal thyroid function results at screening that are clinically significant;
- A history of moderate to severe depression, anxiety disorder, or a history of serious mental illness, such as schizophrenia or bipolar disorder; Or previous suicidal tendencies or behaviors;
- A history of dysphagia or any gastrointestinal disorder that affects drug absorption (as determined by the investigator);
- Subjects who cannot tolerate venipunction, have a history of needle fainting and blood fainting;
- Lactose intolerant;
- Those who test positive for drug abuse or have a history of drug abuse in the past five years or have used drugs in the three months prior to screening;
- Subjects who had received a glucose-lowering drug such as GLP-1 receptor agonist, dipeptidyl peptidase-4 (DPP-4) inhibitor, sodium-glucose cotransporter-2 (SGLT-2) inhibitor, insulin, metformin, insulin secretagotropin, or thiazolidinedione (TZD) within 3 months prior to screening;
- Use of drugs that have an impact on body weight in the 3 months prior to screening, including any approved or unapproved weight loss drugs, such as orlistat, lorcasserin, phentermine/topiramate, naltrexone/bupropion, etc.) or Chinese herbs, health products, meal replacements, etc., that affect body weight; Systemic steroid hormone use (intravenous, oral or intra-articular administration), tricyclic antidepressants, psychiatric medications or sedatives (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenethazine, chlorpromazine, thiridazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts); Note: Except cumulative or continuous use of systemic sex hormones for less than 14 days;
- Those who have participated in other drug clinical trials and received any drug in clinical trials within 3 months prior to screening;
- Subjects who have donated blood or lost blood ≥400 mL, received blood transfusion or used blood products in the 3 months prior to screening;
- Smokers or smokers who smoked an average of ≥5 cigarettes per day in the 3 months prior to screening, or who could not stop using any tobacco products during the study;
- Alcoholics or regular drinkers in the three months prior to screening, i.e. those who consume more than 14 standard units of alcohol per week (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or who test positive for blood alcohol at baseline, or who cannot stop using any alcohol-containing products during the test period;
- Untreated or poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at the screening period
- Mean corrected QT interval (corrected by Fridericia's formula) of the three supine 12-lead ECG measurements was >450 msec;
- Periodclinical laboratory examination (local laboratory) results showed any of the following abnormal subjects (re-confirmed once within 1 week if necessary) : alanine aminotransferase (ALT) ≥2.0× upper limit of normal (ULN); Aspartate aminotransferase (AST) ≥2.0×ULN; Blood total bilirubin (TBIL) ≥1.5×ULN; Amylase or lipase >1.5×ULN; Calcitonin ≥50 ng/L; Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 [CKD-EPI formula, see Appendix 4]; Triglyceride (TG) > 500 mg/dl (5.65 mmol/L);
- Subjects tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), human immunodeficiency virus antibody (HIVAb), or Treponema pallidum antibody (TP-Ab);
- Female subjects who are pregnant or breastfeeding, or who test positive for pregnancy;
- Those who consumed an average of excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day during the 3 months prior to screening, or had consumed tea, coffee and/or caffeinated beverages within 48 hours prior to initial dosing, or could not stop drinking during the study;
- Subjects who have been chronically consuming drinks or foods rich in xanthine or grapefruit, or who have taken any products rich in xanthine or grapefruit within 48 hours before the first dose;
- Any other factors that might affect the evaluation of the relevant indicators for this study identified by the investigator that were not suitable for participation.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
About this study
Official title: A Phase Ic Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DA-302168S Tablets in Overweight/Obese Subjects After Multiple Oral Administration
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of continuous oral administration of DA-302168S tablets for 28 days in overweight/obese subjects.
- Conditions
- Overweight and Obesity
- Being tested
- DA-302168S, Placebo of DA-302168S
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-302168SDrug
Titration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude.
Placebo of DA-302168SDrug
Titration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude.
| Study group | Role | What they receive |
|---|---|---|
| DA-302168S | Experimental | Not described Receives: Drug: DA-302168S |
| Placebo of DA-302168S | Placebo comparator | Not described Receives: Drug: Placebo of DA-302168S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
Measured: Through study completion, an average of 49 days.
Secondary outcomes (8)
Cmax
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Tmax
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
AUC0-t
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Cmin
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
PTR
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Swing
Plasma samples were collected at different points for pharmacokinetic analysis.
Measured: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Body Weight
Percentage change in body weight from baseline.
Measured: Day 1, 8, 15, 22, 29.
Changes in glycosylated hemoglobin (HbA1c) relative to baseline after 28 days of administration.
Blood samples will be assessed for HbA1c (glycated hemoglobin)
Measured: Day 1, 29.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start30 Aug 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Hu, Doctor, Principal investigator, The Second Hospital of Anhui Medical UniversityYi Jun Du, Doctor, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541730
- Sponsor's protocol ID
- 2024-CP-DA168-05
- Acronym
- DA168
- Status last verified
- Apr 2025
- First submitted
- 1 Aug 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ic Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DA-302168S Tablets in Overweight/Obese Subjects After Multiple Oral Administration
- ClinicalTrials.gov ID
- NCT06541730
- Acronym / sponsor ID
- DA168 / 2024-CP-DA168-05
- Conditions
- Overweight and Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of continuous oral administration of DA-302168S tablets for 28 days in overweight/obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-302168S | Experimental | Drug: DA-302168S |
| Placebo of DA-302168S | Placebo comparator | Drug: Placebo of DA-302168S |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18~60 years old, male and female.
- Weight: male ≥50 kg, female ≥45 kg, body mass index (BMI) in the range of 24.0 to 35.0 kg/m2.
- Stable weight in the 3 months prior to screening (self-reported weight change less than 5%).
- Subject and his or her spouse or partner did not plan to become pregnant or plan to donate sperm or ovums from 14 days prior to screening to 3 months after the last dose, and agreed to use at least one acceptable method of effective contraception.
- Written informed consent prior to any study specific procedures.
Key exclusion criteria (30 listed)
- Subjects with secondary obesity, such as obesity caused by metabolic diseases (such as Cushing's syndrome, decreased thyroid function, etc.) or drug-induced obesity (such as glucocorticoids, tricyclic antidepressants, atypical antipsychotics, etc.)
- Subjects with clinically significant cardiovascular and cerebrovascular diseases, including a history of angina pectoris, myocardial infarction, stroke or severe peripheral arterial circulation disorder, or transient ischemic attack within 1 year before signing the ICF; There are risk factors for tip torsion ventricular tachycardia. The presence of untreated severe arrhythmias, such as sick sinus syndrome, second or third degree atrioventricular block; New York Heart Association Heart Function Class II-IV heart failure.
- Previous history or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2;
- Subjects with acute pancreatitis or acute cholecystitis within 3 months before signing the ICF, or with chronic pancreatitis in the past, a history of symptomatic gallbladder (such as multiple gallstones, etc.), or a history of pancreatic injury and other high-risk factors that may lead to pancreatitis;
- Had any malignancy within 5 years prior to signing the ICF (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-302168STitration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude. | Drug | DA-302168S |
| Placebo of DA-302168STitration was used in this study, and the initial plan was to dose titration in cohort 1 (15 mg dose group). The titration regimen and titration dose for subsequent cohorts will be determined based on the results of cohort 1, including the starting dose of titration, frequency of administration, and titration amplitude. | Drug | Placebo of DA-302168S |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Through study completion, an average of 49 days.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0.
8 secondary outcomes
Cmax
Time frame: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Tmax
Time frame: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
AUC0-t
Time frame: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Cmin
Time frame: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
PTR
Time frame: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Swing
Time frame: Day 7 to day 8, day 14 to day 15, day 21 to day 22, day 28.
Body Weight
Time frame: Day 1, 8, 15, 22, 29.
Changes in glycosylated hemoglobin (HbA1c) relative to baseline after 28 days of administration.
Time frame: Day 1, 29.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Hu, Doctor principal investigator
The Second Hospital of Anhui Medical University
Yi Jun Du, Doctor principal investigator
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-302168S in people with Overweight and Obesity, run by Chendu DIAO Pharmaceutical Group CO., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Through study completion, an average of 49 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.