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Efficacy, safety and weight loss mechanism of pegylated losartan in obese patients with type 2 diabetes mellitus

Efficacy, safety and weight loss mechanism of pegylated losartan in obese patients with type 2 diabetes mellitus: a multicenter, randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040391
Enrollment
Unknown
Registered
2020-11-28
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obese patients with type 2 diabetes mellitus

Interventions

placebo group:placebo
100ug Group:Losenatide 100ug
200ug Group:Losenatide 200ug
300ug Group:Losenatide 300ug
orlistat group:orlistat

Sponsors

The Second XIANGYA Hospital Of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Volunteer to participate in this clinical study and sign informed consent; 2. Aged from 18 to 70 years old; 3. BMI >=28 kg/m2; 4. The body weight was kept constant for 3 months, and the weight change was less than 5%; 5. After diagnosis, no hypoglycemic drugs were used, or oral administration of hypoglycemic drugs except DPP-4 inhibitor was given after diagnosis, and the treatment dose was stable for 3 months; 6. HbA1c >=7%.

Exclusion criteria

Exclusion criteria: 1. They took weight loss drugs or participated in weight loss study within 3 months before enrollment; 2. Infection and other stress state; 3. Weight loss surgery was performed in the past; 4. Endocrine diseases such as type 1 diabetes, special type diabetes, hypothyroidism, Cushing's syndrome, polycystic ovary syndrome, etc; 5. In the past three months, they have taken drugs known to affect weight or appetite, such as weight loss drugs, corticosteroids, antidepressants, diazepam, nonselective systemic antihistamines, nicotine substitutes, DPP-4 inhibitors, insulin or two or more hypoglycemic drugs; 6. Combined with hyperlipidemia (TG) ? 5.7 mmol/L; 7. He suffered from serious diseases such as cardio cerebrovascular, liver, kidney and hematopoietic system; 8. He suffered from neoplastic diseases, including medullary thyroid carcinoma and multiple endocrine tumor syndrome; 9. Have had or are suffering from pancreatitis; 10. Chronic gastrointestinal disease or malabsorption syndrome; 11. Pregnancy, lactation and nearly 4 months of gestation; 12. Have mental illness and family history; 13. Alcohol addiction or intellectual (cognitive) disorders; 14. Those who can not complete subcutaneous injection by themselves and can not get proper help.

Design outcomes

Primary

MeasureTime frame
Analysis of human body composition;quality of life;Drug compliance;blood sugar;BMI;

Countries

China

Contacts

Public ContactShiping Liu

Endocrinology and Metabolism department, The Second XIANGYA Hospital Of Central South University

shipingliu119@126.com+86 13875856114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026