Weight Management in Adult Patients With Obesity or OverweightPhase 1NCT07205432
Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
A Phase 1 study testing XTL6001 in people with Weight Management in Adult Patients With Obesity or Overweight, run by Shanghai Xitaili Biomedicine Technology co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects. SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management in Adult Patients With Obesity or Overweight
- What is being tested?
- XTL6001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2025to Apr 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and < 65 years at screening.
- Body mass index (BMI) ≥ 18.5 kg/m² and < 28.0 kg/m² at screening.
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
- Age ≥ 18 and < 65 years at screening.
- BMI ≥ 18.5 kg/m2且 < 40.0kg/m².
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- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Stable body weight (fluctuation < 5%) for at least 3 months prior to screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
Who cannot join
- History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
- Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
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- Female subjects with positive pregnancy test or lactation.
- History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
- UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or gastrointestinal surgeries that may compromise safety or data interpretation.
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
- Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
- Female subjects with positive pregnancy test or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100038
Xiao Hua Hao, Ph.D. in Medicine, 010-63926883, xiaohualuck@sina.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects
This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects.
SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.
- Being tested
- XTL6001, Placebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XTL6001Drug
XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases
PlaceboDrug
This intervention contains no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| XTL6001 | Experimental | Interventional: The SAD study involves single administration of XLT6001, while the MAD study involves administration of XLT6001 for no more than 4 weeks. Receives: Drug: XTL6001 |
| Placebo | Placebo comparator | Placebo: The SAD study involves single administration of Placebo, while the MAD study involves administration of Placebo for no more than 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Measured: SAD: up to Day 8 MAD: up to Day 57
Secondary outcomes (15)
The maximum plasma concentration (Cmax) of XTL6001
Cmax - Maximum plasma concentration
Measured: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Tmax of XTL6001
The time to maximum concentration (Tmax) of XTL6001
Measured: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Elimination half-life (T1/2) of XTL6001
t1/2 - Elimination half-life
Measured: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001
AUC0-tau - Area under the plasma concentration-time curve during one dosing interval
Measured: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
AUC0-t of XTL6001
AUC0-t - Area under the plasma concentration-time curve from time zero to the last measurable concentration
Measured: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Body weight
Body weight
Measured: MAD: up to Day57
Body mass index （BMI）
Body mass index
Measured: MAD: up to Day57
Waist circumference
waist circumference
Measured: MAD: up to Day57
Waist-to-hip ratio
waist-to-hip ratio
Measured: MAD: up to Day57
Blood lipids
Total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1 and apolipoprotein B
Measured: MAD: up to Day57
Blood glucose
Blood glucose
Measured: MAD: up to Day57
Insulin
Insulin
Measured: MAD: up to Day57
Uric acid
Uric acid
Measured: MAD: up to Day57
Anti-drug antibodies (ADA)
Incidence of anti-drug antibodies (ADA)
Measured: MAD: up to Day57
ADA
Time to ADA positivity
Measured: MAD: up to D57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start13 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Management in Adult Patients With Obesity or OverweightStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Xitaili Biomedicine Technology co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205432
- Sponsor's protocol ID
- XTL6001-I-C01
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Administration of XTL6001 Injection in Healthy and Obese Subjects
- ClinicalTrials.gov ID
- NCT07205432
- Acronym / sponsor ID
- XTL6001-I-C01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Xitaili Biomedicine Technology co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 Oct 2025 (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.
This is a multicenter, randomized, double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) and multiple ascending dose (MAD) of XTL6001 injection in healthy and obese adult subjects.
SAD study: Includes 5 dose cohorts, with 40 subjects planned for enrollment. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XTL6001 | Experimental | Drug: XTL6001Interventional: The SAD study involves single administration of XLT6001, while the MAD study involves administration of XLT6001 for no more than 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: The SAD study involves single administration of Placebo, while the MAD study involves administration of Placebo for no more than 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 and < 65 years at screening.
- Body mass index (BMI) ≥ 18.5 kg/m² and < 28.0 kg/m² at screening.
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
- Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
- Age ≥ 18 and < 65 years at screening.
Key exclusion criteria (15 listed)
- History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
- Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
- History of acute or chronic pancreatitis.
- Symptomatic gallbladder disease.
- Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
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 |
|---|---|---|
| XTL6001XTL6001 is a triple-target Glucagon-like peptide-1 receptor （GLP-1R） relevant agonist, intending to manage overweight/obesity and other metabolic diseases | Drug | XTL6001 |
| PlaceboThis intervention contains no active ingredients | Drug | Placebo |
Primary outcome
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Time frame: SAD: up to Day 8 MAD: up to Day 57
15 secondary outcomes
The maximum plasma concentration (Cmax) of XTL6001
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Tmax of XTL6001
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Elimination half-life (T1/2) of XTL6001
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Area under the plasma concentration-time curve during one dosing interval (AUC) 0-tau of XTL6001
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
AUC0-t of XTL6001
Time frame: Within 1 hour before each weekly dosing, and at 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours after the first and last dose administration of the target dose level.
Body weight
Time frame: MAD: up to Day57
Body mass index （BMI）
Time frame: MAD: up to Day57
Waist circumference
Time frame: MAD: up to Day57
Waist-to-hip ratio
Time frame: MAD: up to Day57
Blood lipids
Time frame: MAD: up to Day57
Blood glucose
Time frame: MAD: up to Day57
Insulin
Time frame: MAD: up to Day57
Uric acid
Time frame: MAD: up to Day57
Anti-drug antibodies (ADA)
Time frame: MAD: up to Day57
ADA
Time frame: MAD: up to D57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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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.
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 XTL6001 in people with Weight Management in Adult Patients With Obesity or Overweight, run by Shanghai Xitaili Biomedicine Technology 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 9 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 3 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Hua Hao, Ph.D. in Medicine (010-63926883, xiaohualuck@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events) (time frame: SAD: up to Day 8 MAD: up to Day 57). 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 3 Oct 2025.