Efficacy and Safety of Tirzepatide (Spartina) in Chronic Kidney Failure

NCT07176663 | Not Yet Recruiting

• 1 other identifier: SBMU-1404-06
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes management presents a complex clinical scenario marked by several challenges, especially in chronic kidney failure. These include navigating potential drug interactions between oral antidiabetic therapies and other agents. Furthermore, these patients may experience various adverse drug effects, such as lactic acidosis, electrolyte abnormalities such as hypomagnesemia, fluid retention, and lipid derangements, which can further augment overall morbidity. Consequently, many patients receive insulin. However, prolonged intensive insulin therapy may be linked to several adverse outcomes, including an increased risk of hypoglycemia and weight gain. Hence, a common practice is to transition to medications commonly used other populations of patients. With their established benefits on glycemic control, cardiovascular health, renal benefits, and weight management, in conjunction with the aforementioned adverse effects associated with other oral antidiabetics agents, glucagon-like peptide-1 receptor agonists have emerged as an attractive therapeutic option for patients with kidney failure.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• weight loss

  kilogram of weight loss measured by same scale one and three month after injection

Study Arms (1)

Spartina

EXPERIMENTAL

weekly injection of Tirzepatide (Spartina)

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

2.5 mg weekly first month and 5 mg weekly for two month

Also known as: Spartina

Spartina

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years and history of diabetes or BMI over 27

You may not qualify if:

• Previous usage of similar therapy for less than 3 months owing to the inability to capture all efficacy and safety endpoints within this brief timeframe and/or nonadherence to tirzepatide therapy

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Nooshin Dalili

Tehran, 1666663421, Iran

Location

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Nooshin Dalili, MD

  SBMU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nooshin Dalili, MD

CONTACT

00989122404331; dr.nooshindalili@gmail.com

Nooshin Dalili, MD

CONTACT

00989122404331

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nephrology

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 16, 2025
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)