Testing XTL6001 injection for safety in healthy and obese adults
Tests a new injection, XTL6001, against a placebo in adults with obesity or overweight.
Plain-language title generated from the registry record
Registry title: Phase I Study of XTL6001 Injection in Healthy and Obese Subjects
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07205432, who can take part
Where in China
- Beijing Shijitan Hospital, Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Xitaili Biomedicine Technology co., Ltd.
- Trial code
- NCT07205432
- Record updated
- 3 October 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; 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: Clinically significant gastric emptying disorders, chronic use of medications directly affecting gastrointestinal motility, severe chronic gastrointestinal diseases, or prior gastrointestinal surgery; Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer); Malignancy within 5 years prior to screening (except adequately treated non-melanoma skin cancer); History of acute or chronic pancreatitis; Symptomatic gallbladder disease; Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B); 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; Personal/family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2A/2B (MEN 2A/2B); History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening; History of type 1 or type 2 diabetes mellitus, or HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L at screening; Female subjects with positive pregnancy test or lactation; Female subjects with positive pregnancy test or lactation.