Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

NCT06820281 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: U1111-1316-2752
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 1; Diabetes Mellitus; Autoimmune Diseases; Incretins; Physiological Effects of Drugs; Tirzepatide; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Whole-body insulin sensitivity

  Change in insulin sensitivity from baseline, assessed using the hyperinsulinemic-euglycemic clamp (60 mU/m2/min)

  6 weeks

Secondary Outcomes (16)

• Prandial glucagon secretion

  6 weeks

• Glucagon response to hypoglycemia

  6 weeks

• % Time level 2 hypoglycemia

  6 weeks

• % Time level 1 hypoglycemia

  6 weeks

• Resting energy expenditure (REE)

  6 weeks

Other Outcomes (27)

• Diabetes Treatment Satisfaction

  6 weeks

• Metanephrine response to hypoglycemia

  6 weeks

• Normetanephrine response to hypoglycemia

  6 weeks

Study Arms (2)

Tirzepatide 2.5mg weekly

EXPERIMENTAL

Administered subcutaneously.

Drug: Tirzepatide 2.5mg weekly

Placebo

PLACEBO COMPARATOR

Administered subcutaneously.

Drug: Placebo injection (normal saline)

Interventions

Tirzepatide 2.5mg weekly DRUG

Tirzepatide 2.5 mg/0.5 mL solution for injection vial or pre-filled pen. Each vial/ pre-filled pen contains tirzepatide 2.5 mg in 0.5 mL solution (2.5mg in 0.6mL if Kwikpen) Tirzepatide will be administered by drawing up into a syringe, then administering by subcutaneous injection weekly by study nurses.

Tirzepatide 2.5mg weekly

Placebo injection (normal saline) DRUG

Placebo will be given as 0.5mL normal saline (if comparator against vial or pre-filled pen), or 0.6mL (if comparator against Mounjaro Kwikpen), drawn up into a syringe and administered by subcutaneous injection weekly by study nurses.

Placebo

Eligibility Criteria

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

You may qualify if:

• age 18-65 years
• BMI ≥ 27 kg/m2
• HbA1c ≤ 9.0%
• insulin delivery using an automated insulin delivery system
• at least 2 years since diagnosis of type 1 diabetes

You may not qualify if:

• TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; steroids, antipsychotics, immunosuppressants in the last 6 weeks.
• Hypoglycemic unawareness or severe hypoglycemia last 6 months.
• History of seizure disorder.
• History of weight loss surgery.
• eGFR \<60 mL/min/1.73 m2.
• Liver disease (known cirrhosis, LFTs \> 3x upper limit of normal).
• Active malignancy.
• Pregnant, breastfeeding, planning pregnancy within 6 months, or not using adequate contraception.
• History of cardiovascular disease, or coronary event or stroke in last 3 months
• Hemoglobin level \< 13.5 g/dL in men, \< 12.0 g/dL in women

Sponsors & Collaborators

• Garvan Institute of Medical Research: lead

Study Sites (1)

Garvan Institute of Medical Research

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Autoimmune Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Insulin Resistance

Interventions

Tirzepatide; Saline Solution

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Immune System Diseases; Nutrition Disorders; Hyperinsulinism

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jennifer R Snaith, MD PHD

  Victor Chang Cardiac Research Institute

  PRINCIPAL INVESTIGATOR

• Jerry R Greenfield, MD PHD

  Victor Chang Cardiac Research Institute

  STUDY DIRECTOR

Central Study Contacts

Jennifer R Snaith, MD PHD

CONTACT

+61 2 9295 8600; j.snaith@victorchang.edu.au

Jerry R Greenfield, MD PHD

CONTACT

j.greenfield@victorchang.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment, 1:1 randomization

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)