Trial · Interventional
Active, not recruitingPhase 3Results postedRegistry dataShort name ATTAIN-1
United States, Brazil, China, India, Japan, Puerto Rico, Slovakia, South Korea, Spain, Taiwan
1 trial · 1 ongoing · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Placebo comparator
Placebo
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
Experimental
6 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
Experimental
12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
Experimental
36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
Outcomes the sponsor listed as primary.
Percent Change From Baseline in Body Weight (Primary Treatment Period)
Time frame · 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.
Change From Baseline in Waist Circumference (Primary Treatment Period)
Time frame · 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.
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time frame · 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.
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
Time frame · 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.
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time frame · 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.
Change From Baseline in HbA1c (Primary Treatment Period)
Time frame · 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.
Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period)
Time frame · 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.
Percent Change From Baseline in Fasting Insulin (Primary Treatment Period)
Time frame · 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.
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time frame · 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.
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
Time frame · 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.
Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
Time frame · Baseline, Week 176
Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
Time frame · Baseline through Week 176, Baseline through Week 190
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -0.87 | 0.247 |
| 6 mg Orforglipron | -7.82 | 0.302 |
| 12 mg Orforglipron | -9.27 | 0.335 |
| 36 mg Orforglipron | -12.35 | 0.364 |
| Group | Value (centimeters) | Spread |
|---|---|---|
| Placebo | -2.09 | 0.260 |
| 6 mg Orforglipron | -7.54 | 0.305 |
| 12 mg Orforglipron | -9.00 | 0.318 |
| 36 mg Orforglipron | -11.13 | 0.318 |
| Group | Value (millimeters of mercury (mmHg)) | Spread |
|---|---|---|
| Placebo | -0.78 | 0.404 |
| Pooled 6 mg/12 mg/36 mg Orforglipron | -6.14 | 0.283 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -1.41 | 0.715 |
| Pooled 6 mg/12 mg/36 mg Orforglipron | -7.57 | 0.454 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -4.8 | 1.21 |
| Pooled 6 mg/12 mg/36 mg Orforglipron | -16.4 | 0.74 |
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| Placebo | -0.03 | 0.010 |
| 6 mg Orforglipron | -0.31 | 0.010 |
| 12 mg Orforglipron | -0.31 | 0.010 |
| 36 mg Orforglipron | -0.38 | 0.011 |
| Group | Value (milligram per deciliter (mg/dL)) | Spread |
|---|---|---|
| Placebo | 0.28 | 0.407 |
| 6 mg Orforglipron | -7.68 | 0.341 |
| 12 mg Orforglipron | -8.70 | 0.334 |
| 36 mg Orforglipron | -9.25 | 0.378 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -7.30 | 2.211 |
| 6 mg Orforglipron | -20.64 | 1.967 |
| 12 mg Orforglipron | -23.87 | 2.047 |
| 36 mg Orforglipron | -32.78 | 1.875 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally QD, for a period of 72 weeks. | 1 / 948 | 46 / 948 | 557 / 948 |
| 6 mg OrforglipronPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72. | 1 / 723 | 40 / 723 | 520 / 723 |
| 12 mg OrforglipronPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72. | 1 / 724 | 39 / 724 | 544 / 724 |
| 36 mg OrforglipronPrimary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72. | 0 / 728 | 28 / 728 | 550 / 728 |
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
Studies that cite this trial.
3 studies on this page
PubMed tag: none · 2026
Horn et al. 2026Obesity pillars
PMID 42577069PMC13453602DOI 10.1016/j.obpill.2026.100301PUB-42577069
PubMed tag: none · 2026
Shinde et al. 2026Diabetes, obesity & metabolism
PMID 42750540DOI 10.1111/dom.71322PUB-42750540
Indexing hint: Randomized controlled trial · 2025
Wharton et al. 2025The New England journal of medicinecited by 65
PMID 40960239DOI 10.1056/nejmoa2511774PUB-40960239
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