A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

NCT05869903
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
3,127
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Lead sponsor
Eli Lilly and Company
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Start date
2023-06-05
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Number of sites
138
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Summary
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
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Acronym
ATTAIN-1
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Short title
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
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Official title
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-10-01
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First posted
2023-05-22
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Registry last updated
2026-08-14
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Primary completion date
2025-07-25
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Start date
2023-06-05
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Actual participants
3,127
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Participants
3,127
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
138
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05869903
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ClinicalTrials.gov ID
NCT05869903
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change From Baseline in Body Weight (Primary Treatment Period)

    Timeframe: Baseline, Week 72

    Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  1. Change From Baseline in Waist Circumference (Primary Treatment Period)

    Timeframe: Baseline, Week 72

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  2. Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Timeframe: Baseline, Week 72

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  3. Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Timeframe: Baseline, Week 72

    Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  4. Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Timeframe: Baseline, Week 72

    Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  5. Change From Baseline in HbA1c (Primary Treatment Period)

    Timeframe: Baseline, Week 72

    * Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time. * Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  6. Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period)

    Timeframe: Baseline, Week 72

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  7. Percent Change From Baseline in Fasting Insulin (Primary Treatment Period)

    Timeframe: Baseline, Week 72

    * Fasting insulin is a blood test that measures the level of insulin in the blood after fasting. * Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  8. Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Timeframe: Baseline, Week 72

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.

  9. Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical Component and Mental Component) Scores - (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period

    Timeframe: Baseline, Week 72

    The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.

  10. Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)

    Timeframe: Baseline, Week 176

  11. Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)

    Timeframe: Baseline through Week 176, Baseline through Week 190

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Have a BMI

    • ≥30.0 kilogram/square meter (kg/m²),

    • ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

      • Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).

  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

  • Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
  • Have had a history of chronic or acute pancreatitis.
Sources for eligibility
clinicaltrials.gov

  • The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, United States
  • Clinical Research Institute of Arizona (CRI) - Sun City WestSun City West, United States
  • John Muir Physician Network Research CenterConcord, United States
  • AMCR InstituteEscondido, United States
  • NorCal Medical Research, IncGreenbrae, United States
  • Velocity Clinical Research, Huntington ParkHuntington Park, United States
  • Velocity Clinical Research, WestlakeLos Angeles, United States
  • Catalina Research Institute, LLCMontclair, United States
  • Norcal Endocrinology & Internal MedicineSan Ramon, United States
  • University Clinical Investigators, Inc.Tustin, United States
  • University of Colorado Anschutz Medical CampusAurora, United States
  • New Age Medical Research CorporationMiami, United States
  • South Broward ResearchMiramar, United States
  • Renstar Medical ResearchOcala, United States
  • Jedidiah Clinical Research - Tampa - Bay PlazaTampa, United States
  • Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United States
  • Physicians Research AssociatesLawrenceville, United States
  • East Coast Institute for Research, LLCMacon, United States
  • Rophe Adult and Pediatric Medicine/SKYCRNGUnion City, United States
  • East-West Medical Research InstituteHonolulu, United States
  • Elite Clinical TrialsBlackfoot, United States
  • Cotton O'Neil Clinical Research CenterTopeka, United States
  • Cotton O'Neil Diabetes & EndocrinologyTopeka, United States
  • Pennington Biomedical Research CenterBaton Rouge, United States
  • Care Access - Lake CharlesLake Charles, United States

And 113 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1289-8877
  • J2A-MC-GZGP
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)