ObesityPhase 3ATTAIN-JNCT05931380
A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease
A Phase 3 study testing Orforglipron in people with Obesity, run by Eli Lilly and Company at 16 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Orforglipron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 16 sitesJapan
- Study dates
- 31 Jul 2023to 19 Jun 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 %.
Show all 11Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Yotsuya Medical Cube
Chiyoda City, Tokyo, 102-0084
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Hiroshima Station Clinic
Hiroshima, 732-0053
Shonan Takai Clinic
Kamakura, Kanagawa, 247-0055
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056
Shiraiwa Medical Clinic
Kashihara, Osaka, 582-0005
Sugiura Clinic
Kawaguchi, Saitama, 332-0012
Nishiyamadou Keiwa Hospital
Naka, Ibaraki, 311-0133
Osaka Nishiumeda Clinic
Osaka, 530-0001
Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
Sagamihara, Kanagawa, 252-0302
Heishinkai Medical Group ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, 300-0062
Ohishi Internal Medicine Clinic
Tsuchiura, Ibaraki, 300-0835
About this study
Official title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease
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.
- Conditions
- Obesity
- Being tested
- Orforglipron, Placebo
- Keywords
- Overweight, Metabolism and Nutrition Disorder
- Medical subject headings
- Obesity, Overweight, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrforglipronDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Placebo QD | Placebo comparator | 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. Receives: Drug: Placebo |
| 6 mg Orforglipron QD | Experimental | 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. Receives: Drug: Orforglipron |
| 12 mg Orforglipron QD | Experimental | 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. Receives: Drug: Orforglipron |
| 36 mg Orforglipron QD | Experimental | 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. Receives: Drug: Orforglipron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight at Week 72
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).
Measured: Baseline, Week 72
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
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.
Measured: Baseline to Week 72
Secondary outcomes (20)
Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline
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.
Measured: Baseline to Week 72
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline
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.
Measured: Baseline to Week 72
Percentage of Participants Who Achieved ≥20% Body Weight Reduction From Baseline
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.
Measured: Baseline to Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
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.
Measured: Baseline, Week 72
Percentage of Participants Who Had Improvements in Hypertension
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.
Measured: Baseline to Week 72
Percentage of Participants Who Had Improvements in Dyslipidemia
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.
Measured: Baseline to Week 72
Percentage of Participants Who Achieve Hemoglobin A1c (HbA1c) Target Value (<6.5% [48 mmol/Mol])
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.
Measured: Baseline to Week 72
Mean Change From Baseline in Visceral Adipose Tissue (VAT) at Week 72
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).
Measured: Baseline, Week 72
Mean Change From Baseline in Waist Circumference at Umbilical Level at Week 72
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).
Measured: Baseline, Week 72
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
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).
Measured: Baseline, Week 72
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) at Week 72
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.
Measured: Baseline, Week 72
Percent Change From Baseline in High Density Lipoprotein (HDL) at Week 72
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.
Measured: Baseline, Week 72
Percent Change From Baseline in Triglycerides at Week 72
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.
Measured: Baseline, Week 72
Mean Change From Baseline in Fasting Glucose at Week 72
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).
Measured: Baseline, Week 72
Mean Change From Baseline in Hemoglobin A1c (HbA1c) at 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 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).
Measured: Baseline, Week 72
Mean Change From Baseline in High-sensitivity C-reactive Protein at 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 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.
Measured: Baseline, Week 72
Time to Onset of Type 2 Diabetes (T2D)
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.
Measured: Up to Week 72
Mean Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form For Domain and Component Scores at Week 72
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.
Measured: Baseline, Week 72
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
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.
Measured: Baseline, Week 72
Pharmacokinetics (PK): Mean Plasma Concentration of Orforglipron
Plasma concentrations of orforglipron were measured at predefined pre-dose and post-dose sampling time points.
Measured: Pre-dose at Weeks 8, 24, and 48; post-dose at Week 16 (4 to 12 hours) and Week 36 (1 to 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start31 Jul 2023
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931380
- Sponsor's protocol ID
- 18744
- Other IDs
- J2A-JE-GZPD
- Acronym
- ATTAIN-J
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2023
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Yokote K, Yamauchi T, Shingaki T, Chin R, Oura T, Nagai Y, Shimomura I, Kadowaki T. Efficacy and safety of oral orforglipron in Japanese participants with obesity disease (ATTAIN-J): a double-blind, randomised, placebo-controlled, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2026 Oct 30:S2213-8587(26)00232-9. doi: 10.1016/S2213-8587(26)00232-9. Online ahead of print.
PubMed 42962687
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease
- ClinicalTrials.gov ID
- NCT05931380
- Acronym / sponsor ID
- ATTAIN-J / 18744
- Conditions
- Obesity
- Keywords
- Overweight, Metabolism and Nutrition Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo QD | Placebo comparator | Drug: PlaceboParticipants 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. |
| 6 mg Orforglipron QD | Experimental | Drug: OrforglipronParticipants 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. |
| 12 mg Orforglipron QD | Experimental | Drug: OrforglipronParticipants 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. |
| 36 mg Orforglipron QD | Experimental | Drug: OrforglipronParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- For participants with Type 2 Diabetes (T2D):
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrforglipronAdministered orally | Drug | 12 mg Orforglipron QD, 36 mg Orforglipron QD, 6 mg Orforglipron QD |
| PlaceboAdministered orally | Drug | Placebo QD |
Primary outcome
Percent Change From Baseline in Body Weight at Week 72
Time frame: Baseline, Week 72
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).
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Time frame: Baseline to Week 72
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.
20 secondary outcomes
Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline
Time frame: Baseline to Week 72
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline
Time frame: Baseline to Week 72
Percentage of Participants Who Achieved ≥20% Body Weight Reduction From Baseline
Time frame: Baseline to Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
Time frame: Baseline, Week 72
Percentage of Participants Who Had Improvements in Hypertension
Time frame: Baseline to Week 72
Percentage of Participants Who Had Improvements in Dyslipidemia
Time frame: Baseline to Week 72
Percentage of Participants Who Achieve Hemoglobin A1c (HbA1c) Target Value (<6.5% [48 mmol/Mol])
Time frame: Baseline to Week 72
Mean Change From Baseline in Visceral Adipose Tissue (VAT) at Week 72
Time frame: Baseline, Week 72
Mean Change From Baseline in Waist Circumference at Umbilical Level at Week 72
Time frame: Baseline, Week 72
Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
Time frame: Baseline, Week 72
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) at Week 72
Time frame: Baseline, Week 72
Percent Change From Baseline in High Density Lipoprotein (HDL) at Week 72
Time frame: Baseline, Week 72
Percent Change From Baseline in Triglycerides at Week 72
Time frame: Baseline, Week 72
Mean Change From Baseline in Fasting Glucose at Week 72
Time frame: Baseline, Week 72
Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 72
Time frame: Baseline, Week 72
Mean Change From Baseline in High-sensitivity C-reactive Protein at Week 72
Time frame: Baseline, Week 72
Time to Onset of Type 2 Diabetes (T2D)
Time frame: Up to Week 72
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
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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42962687Yokote K, Yamauchi T, Shingaki T, Chin R, Oura T, Nagai Y, Shimomura I, Kadowaki T. Efficacy and safety of oral orforglipron in Japanese participants with obesity disease (ATTAIN-J): a double-blind, randomised, placebo-controlled, parallel-group, phase 3 trial. Lancet Diabetes Endocrinol. 2026 Oct 30:S2213-8587(26)00232-9. doi: 10.1016/S2213-8587(26)00232-9. Online ahead of print.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orforglipron in people with Obesity, run by Eli Lilly and Company at 16 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight at Week 72 (time frame: Baseline, Week 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.