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Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
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
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
1
Enrollment
80
estimated
Study population
Healthy volunteers, Obesity / overweight
Key I/E criterion
•BMI ≥18.5
Primary endpoint
•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Inclusion Criteria for Subjects in SAD part:
1. Age ≥ 18 and < 65 years at screening.
2. Body mass index (BMI) ≥ 18.5 kg/m² and < 28.0 kg/m² at screening.
3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
4. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
Inclusion Criteria for Subjects in MAD part:
1. Age ≥ 18 and < 65 years at screening.
2. BMI ≥ 18.5 kg/m2且 < 40.0kg/m².
3. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening.
4. Stable body weight (fluctuation < 5%) for at least 3 months prior to screening.
5. Signed informed consent form prior to the trial, with full understanding of the study objectives, procedures, and potential adverse reactions.
Exclusion criteria
Exclusion Criteria for Subjects in SAD part:
1. History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
2. Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery.
3. History of acute or chronic pancreatitis.
4. Symptomatic gallbladder disease.
5. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
6. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
7. Female subjects with positive pregnancy test or lactation.
Exclusion Criteria for Subjects in MAD part:
1. History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening.
2. UnderlyingCushing's syndrome, hypothyroidism, PCOS,.
3. 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.
4. History of acute or chronic pancreatitis.
5. Symptomatic gallbladder disease.
6. Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer).
7. Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B).
8. Female subjects with positive pregnancy test or lactation.
Endpoints (16)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
4 endpointsBody weight
Time frame:MAD: up to Day57
descriptive, improvement
Body mass index (BMI)
Time frame:MAD: up to Day57
descriptive
Waist circumference
Time frame:MAD: up to Day57
Waist circumference, change
change from baseline, improvement
Waist-to-hip ratio
Time frame:MAD: up to Day57
ratio, improvement
Glycemic / diabetes
2 endpointsBlood glucose
Time frame:MAD: up to Day57
descriptive, improvement
Insulin
Time frame:MAD: up to Day57
descriptive
Cardiometabolic biomarkers
1 endpointBlood lipids
Time frame:MAD: up to Day57
change from baseline, improvement
Safety / tolerability / PK
8 endpointsIncidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Time frame:SAD: up to Day 8 MAD: up to Day 57
Treatment-emergent AEs (any)
descriptive, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
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.
Cmax
concentration, descriptive
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.
Tmax
descriptive
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.
Half-life
descriptive
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–∞
concentration, descriptive
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.
AUC₀–∞
concentration, descriptive
Anti-drug antibodies (ADA)
Time frame:MAD: up to Day57
Immunogenicity (ADA)
descriptive
ADA
Time frame:MAD: up to D57
Immunogenicity (ADA)
time to event, event
Other (unclassified)
1 endpointUric acid
Time frame:MAD: up to Day57
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.