Actively Recruiting
Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
Led by Shanghai Xitaili Biomedicine Technology co., Ltd. · Updated on 2025-10-03
80
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to under 65 years at screening
- For SAD part: BMI between 18.5 and less than 28.0 kg/m²
- For MAD part: BMI between 18.5 and less than 40.0 kg/m²
- Body weight at least 50.0 kg for males and at least 45.0 kg for females at screening
- Stable body weight with less than 5% fluctuation for at least 3 months prior to screening (MAD part only)
- Signed informed consent with full understanding of study objectives, procedures, and potential adverse reactions
You will not qualify if you...
- History of type 1 or type 2 diabetes mellitus, or HbA1c greater than 6.5% or fasting plasma glucose over 7.0 mmol/L at screening
- Clinically significant gastric emptying disorders or severe chronic gastrointestinal diseases
- Chronic use of medications that affect gastrointestinal motility
- Prior gastrointestinal surgery that may affect safety or data interpretation
- History of acute or chronic pancreatitis
- Symptomatic gallbladder disease
- Malignancy within 5 years prior to screening (except treated non-melanoma skin cancer)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2A/2B
- Female subjects with positive pregnancy test or who are lactating
- Underlying Cushing's syndrome, hypothyroidism, or polycystic ovary syndrome (MAD part only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
Research Team
X
Xiao Hua Hao, Ph.D. in Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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