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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

Short name ATTAIN-J

NCTNCT05931380 (opens ClinicalTrials.gov in a new tab)Other id18744Other idJ2A-JE-GZPD
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
238 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
31 Jul 2023
Primary completion
19 Jun 2025
Completion
19 Jun 2025
First posted
5 Jul 2023
Last update posted
20 Jul 2026
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

    ATTAIN-J

    NCT05931380

    31 Jul 2023 to 19 Jun 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.

Interventions

  • OrforglipronDrug
  • PlaceboDrug

Arms4

  • Placebo comparator

    Placebo QD

    Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 mg equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

  • Experimental

    6 mg Orforglipron QD

    Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

  • Experimental

    12 mg Orforglipron QD

    Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

  • Experimental

    36 mg Orforglipron QD

    Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Body Weight at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values reported as "LS Mean" are model-based estimates (MBE) of the adjusted (unconditional) treatment effect. MBEs was calculated using an analysis of covariance (ANCOVA) model with the following variables: treatment group, baseline value, baseline Body Mass Index (BMI) category (\<35 kilogram per meter square \[kg/m²\] or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).

  2. Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline

    Time frame · Baseline to Week 72

    Registry description

    Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: treatment group, baseline value, baseline BMI category (\<35 kg/m² or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Stratification factors were defined by the combination of sex (female, male) and baseline type 2 diabetes status (yes, no). The model also allowed the treatment effect to vary across baseline values and stratification factors.

Secondary outcomes(20)

  1. Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline

    Time frame · Baseline to Week 72

    Registry description

    Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with the following variables: treatment group, baseline value, baseline BMI category (\<35 kg/m² or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Stratification factors were defined by the combination of sex (female, male) and baseline type 2 diabetes status (yes, no). The model also allowed the treatment effect to vary across baseline values and stratification factors.

  2. Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline

    Time frame · Baseline to Week 72

    Registry description

    Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with the following variables: treatment group, baseline value, baseline BMI category (\<35 kg/m² or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Stratification factors were defined by the combination of sex (female, male) and baseline type 2 diabetes status (yes, no). The model also allowed the treatment effect to vary across baseline values and stratification factors.

  3. Percentage of Participants Who Achieved ≥20% Body Weight Reduction From Baseline

    Time frame · Baseline to Week 72

    Registry description

    Percentage of participants with ≥20% body weight reduction was analysed by Logistic regression with the following variables: treatment group, baseline value, baseline BMI category (\<35 kg/m² or ≥35 kg/m²), and stratification factors (sex and baseline type 2 diabetes status). Stratification factors were defined by the combination of sex (female, male) and baseline type 2 diabetes status (yes, no). The model also allowed the treatment effect to vary across baseline values and stratification factors.

  4. Change From Baseline in Body Mass Index (BMI) at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values reported as "LS Mean" are model-based estimates (MBE) of the adjusted (unconditional) treatment effect. MBE was calculated using an ANCOVA model with the following variables: baseline, treatment, baseline BMI group, and strata in the model, including treatment-by-baseline and treatment-by-strata interaction terms. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no). The model also allowed the treatment effect to vary across baseline values and stratification factors.

  5. Percentage of Participants Who Had Improvements in Hypertension

    Time frame · Baseline to Week 72

    Registry description

    Percentage of participants achieving hypertension improvement ((Systolic blood pressure \<130 mmHg and diastolic blood pressure \<80 mmHg) was analysed using logistic regression with the following variables: treatment, baseline BMI group, and strata in the model. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no). The estimates (odds ratio and corresponding confidence intervals) were derived using observed data.

  6. Percentage of Participants Who Had Improvements in Dyslipidemia

    Time frame · Baseline to Week 72

    Registry description

    Percentage of participants achieving dyslipidemia improvement (Low-density lipoprotein cholesterol \<140 milligrams per deciliter (mg/dL), triglycerides \<150 mg/dL, and high-density lipoprotein cholesterol ≥40 mg/dL) was analysed using logistic regression with the following variables: treatment, baseline BMI group, and strata in the model. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no). The estimates (odds ratio and corresponding confidence intervals) were derived using observed data.

  7. Percentage of Participants Who Achieve Hemoglobin A1c (HbA1c) Target Value (<6.5% [48 mmol/Mol])

    Time frame · Baseline to Week 72

    Registry description

    Percentage of participants achieving HbA1c \<6.5% was analysed using logistic regression with the following variables: baseline, treatment, baseline BMI group, and sex in the model, including treatment-by-baseline and treatment-by-sex interaction terms.

  8. Mean Change From Baseline in Visceral Adipose Tissue (VAT) at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA model with the following variables: baseline, treatment, baseline BMI group, and strata in the model, including treatment-by-baseline and treatment-by-strata interaction terms. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).

  9. Mean Change From Baseline in Waist Circumference at Umbilical Level at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA model with the following variables: baseline, treatment, baseline BMI group, and strata in the model, including treatment-by-baseline and treatment-by-strata interaction terms. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).

  10. Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA model with the following variables: baseline, treatment, baseline BMI group, and strata in the model, including treatment-by-baseline and treatment-by-strata interaction terms. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).

  11. Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented as LS means are model-based estimates (MBE) of the unconditional average treatment effect on the log-transformed scale. MBE was calculated using an ANCOVA model for log(Actual Value/Baseline), including log-transformed baseline, treatment, baseline BMI group, and strata (defined by joint levels of sex \[female, male\] and baseline type 2 diabetes status \[yes, no\]) as covariates, with treatment-by-log(baseline) and treatment-by-strata interaction terms included in the model.

  12. Percent Change From Baseline in High Density Lipoprotein (HDL) at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented as LS means are model-based estimates (MBE) of the unconditional average treatment effect on the log-transformed scale. MBE was calculated using an ANCOVA model for log(Actual Value/Baseline), including log-transformed baseline, treatment, baseline BMI group, and strata (defined by joint levels of sex \[female, male\] and baseline type 2 diabetes status \[yes, no\]) as covariates, with treatment-by-log(baseline) and treatment-by-strata interaction terms included in the model.

  13. Percent Change From Baseline in Triglycerides at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented as LS means are model-based estimates (MBE) of the unconditional average treatment effect on the log-transformed scale. MBE was calculated using an ANCOVA model for log(Actual Value/Baseline), including log-transformed baseline, treatment, baseline BMI group, and strata (defined by joint levels of sex \[female, male\] and baseline type 2 diabetes status \[yes, no\]) as covariates, with treatment-by-log(baseline) and treatment-by-strata interaction terms included in the model.

  14. Mean Change From Baseline in Fasting Glucose at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using an ANCOVA model with the following variables: baseline, treatment, baseline BMI group, and strata in the model, including treatment-by-baseline and treatment-by-strata interaction terms. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).

  15. Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 72

    Time frame · Baseline, Week 72

    Registry description

    * 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 an ANCOVA model with the following variables: baseline, treatment, baseline BMI group, and strata in the model, including treatment-by-baseline and treatment-by-strata interaction terms. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no).

  16. Mean Change From Baseline in High-sensitivity C-reactive Protein at Week 72

    Time frame · Baseline, Week 72

    Registry description

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed model for repeated measures (MMRM) with the following variables: baseline BMI group, baseline-by-time-by-treatment, and strata-by-time-by-treatment interaction terms in the model. Strata were defined by joint levels of sex (female, male) and baseline type 2 diabetes status (yes, no). An unstructured variance-covariance matrix was used.

  17. Time to Onset of Type 2 Diabetes (T2D)

    Time frame · Up to Week 72

    Registry description

    Time to event was defined as the duration from randomization to adjudication committee-confirmed diagnosis of type 2 diabetes mellitus (T2D). Descriptive statistics are presented as Kaplan-Meier estimates of time to onset of T2D (in weeks). Time to onset of T2D was also analyzed using a Cox proportional hazards model, with treatment (pooled orforglipron dose groups) and sex as factors and baseline fasting serum glucose as a covariate. Hazard ratios with corresponding confidence intervals were estimated and reported in statistical analysis. Statistical significance between treatment groups was assessed using a two-sided log-rank test.

  18. Mean Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form For Domain and Component Scores at Week 72

    Time frame · Baseline, Week 72

    Registry description

    The SF-36v2 acute form, 1-week recall assesses participants' health-related quality of life on 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Each domain is scored individually and information from these 8 domains is further aggregated into 2 health component summary scores, a Physical Component Summary, and a 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 mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.

  19. Mean Change From Baseline in Impact of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) of Physical Function, Physical, and Psychosocial Composite Score at Week 72

    Time frame · Baseline, Week 72

    Registry description

    The IWQOL-Lite-CT is a 20-item, obesity-specific patient reported outcome instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life: physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. The two domain scores (Physical and Psychosocial) and composite score (Physical function) range from 0 to 100 with higher scores indicating greater functioning. Raw scores are then linearly transformed to a 0 (worst) -100 (best) scale using: 100×(average item score-1)/4. Higher scores indicate better quality of life/function; lower scores indicate greater impairment.

  20. Pharmacokinetics (PK): Mean Plasma Concentration of Orforglipron

    Time frame · Pre-dose at Weeks 8, 24, and 48; post-dose at Week 16 (4 to 12 hours) and Week 36 (1 to 4 hours)

    Registry description

    Plasma concentrations of orforglipron were measured at predefined pre-dose and post-dose sampling time points.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 72

Percent Change From Baseline in Body Weight at Week 72

GroupValue (percent change)Spread
Placebo QD-0.630.732
6 mg Orforglipron QD-5.900.866
12 mg Orforglipron QD-8.691.136
36 mg Orforglipron QD-7.931.063
Primary outcomeNumber· Baseline to Week 72

Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline

GroupValue (Percentage of Participants)
Placebo QD15.00
6 mg Orforglipron QD45.90
12 mg Orforglipron QD61.40
36 mg Orforglipron QD58.33
Secondary and other outcome results(6)
Secondary outcomeNumber· Baseline to Week 72

Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline

GroupValue (Percentage of Participants)
Placebo QD3.33
6 mg Orforglipron QD18.03
12 mg Orforglipron QD35.09
36 mg Orforglipron QD38.33
Secondary outcomeNumber· Baseline to Week 72

Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline

GroupValue (Percentage of Participants)
Placebo QD0
6 mg Orforglipron QD9.84
12 mg Orforglipron QD22.81
36 mg Orforglipron QD18.33
Secondary outcomeNumber· Baseline to Week 72

Percentage of Participants Who Achieved ≥20% Body Weight Reduction From Baseline

GroupValue (Percentage of Participants)
Placebo QD0
6 mg Orforglipron QD3.28
12 mg Orforglipron QD12.28
36 mg Orforglipron QD8.33
Secondary outcomeLeast squares mean· Baseline, Week 72

Change From Baseline in Body Mass Index (BMI) at Week 72

GroupValue (kilograms per meter square (kg/m^2))Spread
Placebo QD-0.210.230
6 mg Orforglipron QD-1.940.271
12 mg Orforglipron QD-2.830.354
36 mg Orforglipron QD-2.630.355
Secondary outcomeNumber· Baseline to Week 72

Percentage of Participants Who Had Improvements in Hypertension

GroupValue (Percentage of Participants)
Placebo QD14.9
6 mg Orforglipron QD34.7
12 mg Orforglipron QD30.0
36 mg Orforglipron QD23.5
Secondary outcomeNumber· Baseline to Week 72

Percentage of Participants Who Had Improvements in Dyslipidemia

GroupValue (Percentage of Participants)
Placebo QD60.9
6 mg Orforglipron QD57.4
12 mg Orforglipron QD63.6
36 mg Orforglipron QD65.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo QDParticipants received matching placebo capsule orally once daily. Treatment was initiated with placebo corresponding to 1 mg equivalent, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.0 / 605 / 6047 / 60
6 mg Orforglipron QDParticipants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.0 / 611 / 6151 / 61
12 mg Orforglipron QDParticipants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.0 / 573 / 5748 / 57
36 mg Orforglipron QDParticipants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose interruption or modification was required. Treatment was administered as an adjunct to a reduced-calorie diet and increased physical activity.1 / 606 / 6051 / 60

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Participants with a BMI ≥27 kg/m² and \<35 kg/m² and at least 2 obesity-related health problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants). * Have a history of at least one self-reported unsuccessful dietary effort to lose body weight. * Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * No male contraception is required except in compliance with specific local government study requirements. Exclusion Criteria: * For participants with Type 2 Diabetes (T2D): * Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. * Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening. * Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening. * Have a known clinically significant gastric emptying abnormality. * For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %. * Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening. * Have chronic kidney disease. * Have lupus or rheumatoid arthritis. * Have the following cardiovascular conditions within 90 days prior to screening. * Have acute or chronic hepatitis.

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