Status:
RECRUITING
Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
Lead Sponsor:
Shanghai Xitaili Biomedicine Technology co., Ltd.
Conditions:
Weight Management in Adult Patients With Obesity or Overweight
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Subjects in SAD part:
- 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.
- Inclusion Criteria for Subjects in MAD part:
- Age ≥ 18 and \< 65 years at screening.
- BMI ≥ 18.5 kg/m2且 \< 40.0kg/m².
- 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.
Exclusion
- Exclusion Criteria for Subjects in SAD part:
- 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).
- Female subjects with positive pregnancy test or lactation.
- Exclusion Criteria for Subjects in MAD part:
- 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.
Key Trial Info
Start Date :
June 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07205432
Start Date
June 13 2025
End Date
April 1 2026
Last Update
October 3 2025
Active Locations (1)
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1
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100038