XTL6001 injection in healthy adults and adults with overweight or obesity

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 trial tests single and multiple doses of XTL6001 injection to see if it is safe and to measure how the drug behaves in healthy adults and adults with overweight or obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Xitaili Biomedicine Technology co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07205432 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase I trial tests single ascending dose (SAD) and multiple ascending dose (MAD) regimens of XTL6001 in healthy and obese adult subjects. The SAD part includes five dose cohorts with about 40 subjects planned and the MAD part includes two dose cohorts with about 30 subjects planned. Primary outcomes are safety and tolerability, with secondary assessments of pharmacokinetics (PK) and pharmacodynamics (PD). Enrollment is conducted at Beijing Shijitan Hospital (Capital Medical University) and participants must meet specified BMI, weight, and screening criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to under 65 who meet the study's BMI and weight criteria—healthy participants with BMI 18.5–<28.0 kg/m² for SAD, and adults with BMI 18.5–<40.0 kg/m² and stable weight for MAD—who consent and pass screening.

Not a fit: People with diabetes (history of type 1 or type 2 diabetes, HbA1c > 6.5% or fasting plasma glucose > 7.0 mmol/L) or other major exclusionary medical conditions are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this early testing could identify safe dose ranges and early signals that XTL6001 may help with weight management.

How similar studies have performed: Early-phase PK/PD trials are a standard first step in obesity drug development and have led to later successes for some drug classes, but XTL6001 itself appears to be a novel agent without published human efficacy results to date.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Shijitan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiao Hua Hao, Ph.D. in Medicine

Conditions Weight Management in Adult Patients With Obesity or Overweight