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

Conditions

• Obesity
• Overweight
• Overweight or Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Orforglipron — DRUG
  Administered orally.
• Placebo — DRUG
  Administered orally.

Study Details

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.

Key Dates

First listed

May 22, 2023

Start date

Jun 5, 2023

Status verified

Jul 2026

Primary completion

Jul 25, 2025

Completion

Oct 31, 2027

Study Design

Enrollment

3,127 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Percent Change From Baseline in Body Weight (Primary Treatment Period) [ Time Frame: Baseline, Week 72 ]

Locations (43)

Related coverage on Hipa.ai

• Orforglipron Phase 3 Trial for Obesity/Overweight Completes Primary Phase
  Orforglipron · Jul 25, 2025 · ClinicalTrials.gov

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