Weight Management in Adult Patients With Obesity or Overweight
Investigational drug(s) / intervention(s)
XTL6001Placebo
XTL6001: XTL6001 is a triple-target Glucagon-like peptide-1 receptor (GLP-1R) relevant agonist, intending to manage overweight/obesity and other metabolic diseases
Placebo: This intervention contains no active ingredients
Study 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. MAD study Includes 2 dose cohorts, with 30 subjects planned for enrollment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events) — SAD: up to Day 8 MAD: up to Day 57
Trial sites (1)
Facility
City
Region
Status
Beijing Shijitan Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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