A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
- Summary
- The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.
- Acronym
- SURPASS-T1D-1
- Short title
- A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Tirzepatide Once Weekly Compared to Placebo in Adult Participants With Type 1 Diabetes and Obesity or Overweight
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-12-01
- First posted
- 2025-04-06
- Registry last updated
- 2026-05-12
- Primary completion date
- 2026-11-01
- Start date
- 2025-04-25
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06914895
- ClinicalTrials.gov ID
- NCT06914895
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Change from Baseline in Hemoglobin A1c (HbA1c)
Timeframe: Baseline, Week 40
Percentage of Time Continuous Glucose Monitor (CGM) Glucose Values are Between 70 and 180 milligrams per deciliter (mg/dL) (3.9 and 10.0 millimoles per liter (mmol/L) Inclusive, Per Day
Timeframe: Within 30 days prior to Week 40
Change from Baseline in Body Weight
Timeframe: Baseline, Week 40
Percent Change from Baseline in Body Weight
Timeframe: Baseline, Week 40
Percentage of Participants with ≥5% Body Weight Reduction
Timeframe: Baseline, Week 40
Percentage of Participants with ≥10% Body Weight Reduction
Timeframe: Baseline, Week 40
Percentage of Participants with ≥15% Body Weight Reduction
Timeframe: Baseline, Week 40
Change from Baseline in Waist Circumference
Timeframe: Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)
Timeframe: Baseline, Week 40
Percent Change from Baseline in Fasting Triglycerides
Timeframe: Baseline, Week 40
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein (non-HDL) Cholesterol
Timeframe: Baseline, Week 40
Percent Change from Baseline in Total Daily Insulin Dose
Timeframe: Baseline, Week 40
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Timeframe: Baseline, Week 40
Change from Baseline in EQ-5D-5L
Timeframe: Baseline, Week 40
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Have type 1 diabetes and on insulin treatment for at least one year prior to screening
- Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
- Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
- Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study
- Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
- Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
- Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have had chronic or acute pancreatitis
- Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening
- Sansum Diabetes Research InstituteSanta Barbara, United States
- Care Access - Santa ClaritaSanta Clarita, United States
- University of Colorado Anschutz Medical CampusAurora, United States
- Atlanta Diabetes AssociatesAtlanta, United States
- Orita Clinical ResearchDecatur, United States
- North Georgia Clinical ResearchWoodstock, United States
- East-West Medical Research InstituteHonolulu, United States
- Rocky Mountain Clinical ResearchIdaho Falls, United States
- Southern Illinois University School of MedicineSpringfield, United States
- Indiana University Health University HospitalIndianapolis, United States
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States
- Endocrine and Metabolic ConsultantsRockville, United States
- HealthPartners Institute dba International Diabetes CenterMinneapolis, United States
- SKY Integrative Medical Center/SKYCRNGRidgeland, United States
- Boeson Research MSOMissoula, United States
- Palm Research Center TenayaLas Vegas, United States
- Palm Research Center SunsetLas Vegas, United States
- Albany Medical College, Division of Community EndocrinologyAlbany, United States
- Research Foundation of SUNY - University of BuffaloBuffalo, United States
- NYC ResearchNew York, United States
- SUNY Upstate Medical UniversitySyracuse, United States
- Lucas Research, Inc.Morehead City, United States
- Care Access - LimaLima, United States
- Alliance for Multispecialty Research, LLCNorman, United States
- Suburban Research AssociatesWest Chester, United States
And 121 more, listed on the interactive page.
- Related resource (trials.lilly.com)
- 2024-519684-17-00
- I8F-MC-GPJA
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Obesity disorder
- Type 1 diabetes mellitus Primary condition